Humira injection pen Uses, Dosage, Side Effects, Precautions & Warnings

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Humira injection pen >>> Generic drug of the Therapeutic Class: Immunology
Active ingredients: Adalimumab

What exactly does Humira do?

• Adalimumab suppresses body defenses and inhibits inflammation.
• In joint inflammations (rheumatism, Bechterew’s disease), inflammatory bowel disease (Crohn’s disease, ulcerative colitis), the skin disease psoriasis and other skin conditions. Furthermore, in the eye disease uveitis and sometimes in sarcoidosis (Besnier-Boeck’s disease).
• Usually you notice within a few weeks that the disease becomes calmer. Do you notice no effect within 2 to 4 months? Your doctor will then look for another medication for you.
• You can administer the medication yourself. The doctor or nurse will explain to you how to do this.
• You usually use an injection once every two weeks; sometimes once a week
• You may experience redness, itching, pain and swelling at the site of the injection. Usually this will change automatically within a few days. Always give the injection in a different place.
• Other side effects: respiratory or other infections, gastrointestinal complaints and headache. Blood disorders can occur after a few weeks to months. The doctor will therefore regularly check your blood. Do you get sore throat, fever or do you get bruises quickly? Then tell your doctor.

what is humira used for and

indication?

Rheumatoid arthritis

Humira in combination with methotrexate is indicated for:

1. the treatment of moderate to severely active rheumatoid arthritis in adults when the response to DMARDs, including methotrexate, is inadequate.
2. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
3. Humira may be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
4. Humira has been shown to slow the progression of X-ray structural joint damage and improve functional abilities when administered in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

1. Humira in combination with methotrexate is indicated for the treatment of progressive polyarticular juvenile idiopathic arthritis in patients from 2 years of age in case of insufficient response to one or more DMARDs.
2. Humira can be given as monotherapy in case of intolerance to methotrexate or when continuation of treatment with methotrexate is inappropriate (for efficacy in monotherapy, ). Humira has not been studied in patients less than 2 years old.

Arthritis related to enthesitis

1. Humira is indicated for the treatment of active arthritis related to enthesitis in patients from 6 years of age in case of insufficient response or intolerance to conventional therapy .

Axial spondyloarthritis

Ankylosing spondylitis (AS)

• Humira is indicated for the treatment of severe and active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Axial spondyloarthritis without radiographic signs of SA

• Humira is indicated for the treatment of severe axial spondyloarthritis without radiographic evidence of SA, but with objective signs of inflammation on MRI and / or elevated CRP in adults with inadequate response or intolerance to -non-steroidal inflammatory drugs.

Psoriatic arthritis

• Humira is indicated for the treatment of active and active psoriatic arthritis in adults when the response to previous background therapy has been inadequate. Humira has been shown to slow the progression of peripheral joint structural damage as measured by radiography in patients with symmetrical polyarticular forms of the disease (see section 5.1 ) and improves functional abilities.

Psoriasis

• Humira is indicated for the treatment of moderate to severe plaque psoriasis in adult patients requiring systemic therapy.

Plaque psoriasis of the child and teenager

• Humira is indicated for the treatment of chronic severe plaque psoriasis in children from 4 years of age and adolescents in case of insufficient response to topical treatment and phototherapy or when these treatments are inappropriate.

Suppurative hidrosadenitis (HS)

• Humira is indicated for the treatment of active, moderate to severe suppurative hidrosadenitis (Verneuil’s disease) in adults and adolescents from 12 years of age when there is insufficient response to conventional systemic treatment of HS (see sections Property pharmacodynamicsand pharmacokinetic properties ).

Crohn’s disease

• Humira is indicated for the treatment of moderate to severe active Crohn’s disease in adult patients who have not responded despite appropriate and well-managed corticosteroid and / or immunosuppressive therapy; or in whom this treatment is contraindicated or poorly tolerated.

Crohn’s disease in children and adolescents

• Humira is indicated for the treatment of moderate to severe active Crohn’s disease in children and adolescents from 6 years of age who have not responded to conventional therapy including first-line and corticosteroid or an immunomodulator, or in which these treatments are poorly tolerated or contraindicated.

Hemorrhagic rectocolitis

• Humira is indicated for the treatment of moderate to severe active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or in which this treatment is contraindicated or poorly tolerated.

uveitis

• Humira is indicated for the treatment of non-infectious, intermediate, posterior uveitis and panuveitis in adult patients who have had an inadequate response to corticosteroid therapy, in patients requiring cortisone sparing, or in whom corticosteroid therapy is inappropriate.

what is the dosage of humira pen?

• Treatment with Humira should be initiated and supervised by a specialist physician qualified in the diagnosis and treatment of the conditions in which Humira is indicated.
• Ophthalmologists are advised to consult an appropriate specialist before initiating Humira therapy (see Warnings and Precautions , Neurological Events section).
• A special surveillance card will be given to patients treated with Humira.
• After proper training in the injection technique, patients can self-inject Humira, if their doctor considers it possible, under the guise of appropriate medical follow-up.
• During treatment with Humira, other concomitant treatments (such as corticosteroids and / or immunomodulators) should be optimized.

Dosage

Rheumatoid arthritis

• In adult patients with rheumatoid arthritis, the recommended dose of Humira is a single dose of 40 mg adalimumab administered every two weeks, subcutaneously. Methotrexate should be continued during treatment with Humira.
• Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may be continued during treatment with Humira. For combination with other non-rheumatic drugs other than methotrexate (see sections Warnings and Precautions and Pharmacodynamic Properties ).
• As monotherapy, some patients who experience a decrease in their response to Humira may benefit from an increase in dosage to 40 mg adalimumab weekly.
• Available data suggest that the clinical response is usually achieved by
• 12 weeks of treatment. Further treatment should be reconsidered in a patient who has not responded within this time frame.

Interruption of treatment

• It may be necessary to stop treatment, for example before surgery or in case of severe infection.
• Available data suggest that re-introduction of Humira after stopping for 70 days or longer results in a similar clinical response and a similar safety profile to that observed before discontinuation of treatment.
• Ankylosing spondylitis, axial spondyloarthritis without radiographic signs of AS and psoriatic arthritis
• The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab single dose every two weeks, by subcutaneous injection. .

Available data suggest that the clinical response is usually achieved by

12 weeks of treatment. Further treatment should be reconsidered in a patient who has not responded within this time frame.

Psoriasis

• The recommended dose of Humira for starting treatment in adults is 80 mg subcutaneously. The dosage will be continued one week later by 40 mg subcutaneously every other week.
• Continuation of treatment beyond 16 weeks should be carefully reconsidered in a patient who has not responded within this time frame.
• Beyond 16 weeks, in case of insufficient response, patients can benefit from an increase in the frequency of administration to 40 mg every week. The benefits and risks of continuous treatment with Humira every week should be carefully reconsidered in a patient if there is insufficient response after increasing the frequency of administration (see section 5.1 ). If a sufficient response is obtained after increasing the frequency of administration, the dose may then be reduced to 40 mg every 2 weeks.

Suppurative hidrosadenitis

• The recommended dosing regimen for Humira in adult patients with suppurative hidrosadenitis (HS) is an initial dose of 160 mg on Day 1 (given as four 40 mg injections on one day or two injections of 40 mg daily for two consecutive days), followed by a dose of 80 mg two weeks later, on Day 15 (given as 2 injections of 40 mg on a day). Two weeks later (Day 29), continue with a dose of 40 mg weekly. If necessary, antibiotics may be continued during treatment with Humira. During treatment with Humira, it is recommended that the patient cleanse their lesions daily with a topical antiseptic.
• Continuation of treatment beyond 12 weeks should be carefully reconsidered in patients with no improvement during this period.
• If treatment is interrupted, Humira 40 mg weekly may be reintroduced .
• The benefit and risk of continued long-term treatment should be regularly evaluated .

Crohn’s disease

• In adult patients with moderate to severe active Crohn’s disease, the recommended induction regimen of Humira is 80 mg at week 0, followed by 40 mg at week 2. If it is necessary to obtain a faster response to treatment, the 160 mg schedule at week 0 (the dose can be given as 4 injections per day or 2 injections per day for two consecutive days), 80 mg at week 2, can be used knowing that the risk of adverse events is higher during this induction phase.
• After induction therapy, the recommended dose is 40 mg administered every two weeks as a subcutaneous injection. If a patient has stopped taking Humira and the signs and symptoms of the disease recur, Humira can be re-administered. The experience of re-administration of treatment beyond 8 weeks after the previous dose is limited.
• During maintenance therapy, corticosteroids may be progressively decreased as recommended by clinical practice.
• Some patients who experience a decrease in the response to treatment may benefit from an increase in the frequency of administration to 40 mg Humira weekly.
• Some patients who did not respond to treatment at week 4 may continue maintenance treatment until week 12. Continuation of treatment should be carefully reconsidered in a patient who has not responded within this time frame.

Hemorrhagic rectocolitis

• In adult patients with moderate to severe ulcerative colitis, the recommended induction regimen of Humira is 160 mg at week 0 (the dose may be administered as 4 injections per day or 2 injections per day two consecutive days) and 80 mg at week 2. After induction therapy, the recommended dose is 40 mg given every two weeks as a subcutaneous injection.
• During maintenance therapy, corticosteroids may be progressively decreased as recommended by clinical practice.
• Some patients who experience a decrease in the response to treatment may benefit from an increase in the frequency of administration to 40 mg Humira weekly.

Available data suggest that the clinical response is usually

8 weeks of treatment. Humira treatment should not be continued in patients who have not responded within this time frame.

uveitis

• In adult patients with uveitis, the recommended dose of Humira is an initial dose of 80 mg followed by a dose of 40 mg every two weeks starting one week after the first dose. Experience with initiation of Humira therapy as monotherapy is limited. Treatment with Humira may be started in combination with corticosteroids and / or other non-biological immunomodulatory therapies. The associated corticosteroid dose may be progressively decreased according to clinical practice, starting two weeks after initiation of Humira treatment.
• An annual reassessment of the benefits and risks associated with long-term continuous therapy is recommended.

Elderly

• No adjustment of the dosage is necessary. Patients with renal and / or hepatic impairment
• Humira has not been studied in these patient populations. It is not possible to recommend dosages.

Pediatric population

Juvenile idiopathic arthritis

Polyarticular Juvenile Idiopathic Arthritis 2-12 Years

• The recommended dose of Humira for patients aged 2 to 12 years with polyarticular juvenile idiopathic arthritis is 24 mg / m 2 body surface area up to a single maximum dose of 20 mg adalimumab (for 2-4 years) and up to a single maximum dose of 40 mg adalimumab (for patients aged 4 to 12 years) every two weeks by subcutaneous injection.
• The injection volume is determined according to the size and weight of the patient (Table 1). A pediatric vial of 40 mg / 0.8 ml is available for patients who require a dose lower than a full dose of 40 mg.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.

Active tuberculosis or other severe infections such as sepsis and opportunistic infections.

Moderate to severe heart failure (NYHA classes III / IV) (see section Special warnings and precautions for use ).

What are the most common side effects of Humira?

In addition to the desired effect, this can cause drug side effects.

The main side effects are the following.

Sometimes (from 10 to 30 people in 100)

• Redness , itching, pain and swelling at the site of injection. This usually changes after a few days.
• Gastrointestinal complaints such as nausea, vomiting and abdominal pain. Rarely bloating, heartburn, belching or bleeding in the stomach or intestines.
• Less red and white blood cells and fewer platelets . You therefore have a higher risk of infections , anemia and bleeding .
  Warn the doctor by sore throat, fever, blisters in the mouth, bruises, nose bleeds, pale skin, severe tiredness, shortness of breath, persistent cough or blood in the urine. Furthermore, if you have an infection, such as boils, shingles, fungal infections on a bladder infection.
  Tuberculosis can occur in rare cases. Before, during and up to 6 months after the last injection, the doctor will have your lungs checked for, among other things, tuberculosis.
• Headache , rarely migraine. In rare cases, headache is the result of meningitis (neck catastrophe, meningitis). Consult your doctor for headaches that last longer than a day.
• Muscle pain or muscle cramp . Usually the muscle pain is harmless, but in very rare cases a serious side effect can occur on the muscles. The symptoms of this serious side effect are muscle pain, muscle weakness, general feeling sick, fever, nausea and vomiting. The muscle pain is usually in the calves or lower back, but the whole body can also do a lot. If you experience these symptoms, you should consult your doctor as soon as possible.
• Too much cholesterol and other fats in the blood. Your doctor will check your blood regularly for this.
• Dry skin , skin rash , itching, hives, inflammation of the skin, sweating and breaking of the nails. Skin rash may be due to hypersensitivity (see Rare ). Consult the doctor for a rash.

Rarely (from 1 to 10 in 100 people)

• Psychological complaints such as anxiety, depression, mood swings and insomnia.
• Spirky feeling . Very rare ringing in the ears, deafness.
• Nervous abnormalities . Warn your doctor if you notice a numb or tingling sensation in the arms or legs. In people with multiple sclerosis (MS) or optic nerve abnormalities, the symptoms can worsen.
• Eye complaints such as painful eyes and inflamed eyes. Very rare double vision and inflammation of the eyelids. It can also reduce vision. Then tell your doctor.
• Dry mucous membranes . This is most noticeable in dry eyes and dry mouth.
• Flushing and dizziness of . These side effects are the result of the blood vessels becoming wider.
• Increased blood pressure, accelerated heartbeat, chest pain and palpitations. Very rarely, a heart attack or stroke can occur. In people with high blood pressure , the doctor will check blood pressure regularly.
• Hypersensitivity . You can notice this by skin rash, hives and itching. Severe hypersensitivity can be seen from chest tightness or a swollen face, lips, mouth, tongue or throat. You can be very stuffy.
  Very rarely, a severe hypersensitivity reaction occurs with red spots and blisters on the skin. In these cases, you should immediately seek out a doctor or go to the First Aid Service. If you are hypersensitive, you should not use adalimumab. Therefore, pass this on to the pharmacist. The pharmacy team can then ensure that you do not get this medication again.

Very rare (affects less than 1 in 100 people)

• People with heart failure may suffer more from their complaints. In the event of increased fluid retention (thick ankles) or shortness of breath, you should warn the doctor.
• Disorders of the liver , pancreas , gallbladder or spleen . Tell your doctor immediately if you have a fever, night sweats, weight loss, abdominal pain, swollen belly, yellow skin color and whites, nausea and dark urine. People who have had hepatitis B before may be given this again.
• Lung disorders . You may notice this by shortness of breath, cough or fever. In some cases severe pneumonia can develop. Consult your doctor when these symptoms occur.
• More risk of chronic diseases , such as lupus erythematodes (LE), blood vessel inflammation (vasculitis), organ inflammation (sarcoidosis), intestinal inflammation.
• More risk of certain types of cancer , such as lymphoma , blood cancer (leukemia), skin cancer, breast cancer, cervical cancer or lung cancer.

Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.

humira drug interactions

• Humira has been studied in patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis taking Humira monotherapy and those taking concomitant methotrexate.
•  Antibody formation was lower when Humira was administered concurrently with methotrexate compared to its use as monotherapy.Administration of Humira without methotrexate resulted in increased antibody formation, increased clearance, and decreased efficacy of adalimumab .
• The combination of Humira and anakinra is not recommended ( Special warnings and precautions for use “Simultaneous administration of biological first-line drugs or α -TNF antagonists “).
• The combination of Humira and abatacept is not recommended. Special warnings and precautions for use “Simultaneous administration of biological DMARDs or TNFα antagonists “.

Humira pen Warnings and Precautions

In order to improve the traceability of biological drugs, the brand name and lot number of the product administered must be clearly recorded.

infections

• Patients receiving TNF antagonists are more prone to severe infections. Impaired lung function may increase the risk of developing infections. Patients should therefore be closely monitored for infections (including tuberculosis) before, during and after treatment with Humira. The duration of elimination of adalimumab can be up to four months, the monitoring should be continued throughout this period.
• Humira treatment should not be initiated until progressive infections, including chronic or localized infections, are controlled. In patients who have been exposed to tuberculosis or who have traveled to areas at high risk of tuberculosis or endemic mycoses, eg histoplasmosis, coccidioidomycosis or blastomycosis, the risks and benefits of Humira treatment should be considered before initiation. treatment (see opportunistic infections).
• Patients who develop a new infection during treatment with Humira should be carefully monitored and a complete diagnostic assessment should be performed. If a new severe infection or sepsis develops, Humira should be discontinued and appropriate antimicrobial or antifungal therapy initiated until the infection is controlled. The physician should exercise caution before using Humira in patients with a history of recurrent infection or under underlying conditions that may predispose them to infections, including concomitant treatment with immunosuppressive drugs.

Serious infections

• Serious infections, including septicemia due to bacterial, mycobacterial, invasive fungal, parasitic, viral or other opportunistic infections, such as listeriosis, legionellosis and pneumocystosis, have been reported in patients treated with Humira.
• Other serious infections observed in clinical trials include pneumonia, pyelonephritis, septic arthritis and sepsis . Cases of infections requiring hospitalization or having a fatal outcome have been reported.

Tuberculosis

• Cases of tuberculosis, including cases of reactivation of tuberculosis and primary tuberculosis infection, have been reported in patients receiving Humira. Cases of pulmonary and extra-pulmonary (ie disseminated) tuberculosis have been reported.
• Before initiating Humira treatment, all patients should be screened for TB infection, active or otherwise (“latent”). This assessment should include a detailed medical assessment in patients with a history of tuberculosis or possible previous exposure to patients with active TB and / or current or past immunosuppressive therapy. Appropriate screening tests (eg, dermal tuberculin test and chest x-ray) should be performed in all patients (according to local recommendations). It is advisable to note the achievement and results of these tests in the patient’s monitoring card.
• If active TB is diagnosed, treatment with Humira should not be initiated.
• In all the situations described below, the benefit / risk ratio of the treatment should be very carefully evaluated.
• In case of suspicion of latent tuberculosis, the consultation of a medical specialist, qualified in the treatment of tuberculosis, should be considered.
• If latent TB is diagnosed, appropriate TB prophylaxis consistent with local recommendations should be initiated prior to initiation of Humira therapy.
• Antituberculosis prophylaxis should also be considered prior to the initiation of Humira in patients with multiple or significant risk factors for tuberculosis despite a negative tuberculosis test and in patients with a history of latent or active tuberculosis. that the administration of appropriate anti-tuberculosis treatment can not be confirmed.
• Cases of reactivation of tuberculosis despite prophylaxis have occurred in patients treated with Humira.Some patients who had been successfully treated for active TB developed the disease again during treatment with Humira.
• Patients should be informed that they should consult their physician if signs or symptoms suggestive of TB infection (eg persistent cough, weight loss / weight loss, fever, apathy) occur during or after treatment with the doctor. Humira.

Other opportunistic infections

• Opportunistic infections, including invasive fungal infections, have been observed in patients treated with Humira. These infections have not always been detected in patients receiving TNF antagonists, which has delayed the initiation of appropriate treatment, sometimes with a fatal outcome.
• In patients with signs and symptoms such as fever, malaise, weight loss, sweating, coughing, dyspnoea and / or pulmonary infiltrates or other severe systemic disease with or without concomitant shock, an invasive fungal infection should be suspected; in this case, the administration of Humira should be stopped immediately. Diagnosis and initiation of empirical antifungal therapy in these patients should be made in consultation with a physician experienced in the management of patients with invasive fungal infections.

Reactivation of hepatitis B

Hepatitis B reactivation occurred in patients who received a TNF antagonist y Comris Humira and who were chronic carriers of this virus (ie, positive surface antigen – HBsAg positive). Some cases have had a fatal outcome. Patients should be screened for HBV infection before initiating Humira treatment. 

For patients for whom the hepatitis B test is positive, it is recommended that you consult a doctor who specializes in the treatment of hepatitis B. HBV carriers who require treatment with Humira should be observed carefully.

signs and symptoms of active HBV infection throughout treatment and for several months after discontinuation. 

He does not There is insufficient data available to treat antiviral-treated HBV patients to prevent reactivation of HBV and treated with a TNF antagonist. 

In patients who develop HBV reactivation, Humira should be discontinued and effective antiviral therapy and appropriate adjunctive therapy initiated.\

Neurological events

TNF antagonists, including Humira, have been associated in rare circumstances with the onset or exacerbation of clinical symptoms and / or radiological signs of demyelinating central nervous system disease including multiple sclerosis, optic neuritis and peripheral demyelinating disease, including Guillain-Barré syndrome. 

Caution should be exercised with prescribers prior to treatment with Humira in patients with demyelinating central or peripheral nervous system disease, pre-existing or recent onset; discontinuation of treatment should be considered if any of these disorders occur.

The association between intermediate uveitis and demyelinating diseases of the central nervous system is known.

Allergic reactions

In clinical trials, serious allergic reactions associated with Humira have been reported rarely and non-serious allergic reactions attributable to Humira have been infrequent. Cases of serious allergic reactions including anaphylactic reactions have been reported after administration of Humira. If an anaphylactic reaction or other severe allergic reaction occurs, the administration of Humira should be stopped immediately and appropriate treatment instituted.

immunosuppression

In a study of 64 patients with rheumatoid arthritis treated with Humira, there was no evidence of delayed-type hypersensitivity depression, decreased immunoglobulin levels, or a change in T and B effector lymphocyte counts, NK lymphocytes, monocytes / macrophages and neutrophil granulocytes.

Malignant neoplasms and lymphoproliferative disorders

• In the controlled part of clinical trials with anti-TNF, more cases of cancer, including lymphoma, were observed in patients treated with anti-TNF than in patients in the control group. However, the incidence was rare. During post-marketing surveillance, cases of leukemia have been reported in patients treated with anti-TNF. In addition, there is a context of increased risk of lymphoma and leukemia in patients with old, inflammatory and highly active rheumatoid arthritis, which complicates the risk assessment. In the current state of knowledge, the possibility of a risk of developing lymphoma, leukemia or other malignant diseases in patients treated with anti-TNF can not be ruled out.
• Malignant tumors, some of them fatal, have been reported post-marketing in children, adolescents, and young adults (up to the age of 22 years) treated with anti-TNF agents (initiation of pre-treatment). 18 years old), including adalimumab. About half of these cases were lymphomas. The other cases corresponded to other types of malignancies, including rare cancers generally associated with an immunosuppressive context. The risk of developing malignant tumors can not be ruled out in children and adolescents treated with anti-TNF.
• During post-marketing surveillance, rare cases of T-cell hepatosplenic lymphoma have been identified in patients treated with adalimumab. This rare form of T lymphoma has a very aggressive evolution and is often fatal. Some of these T-cell hepatosplenic lymphomas have occurred in young adults with concomitant treatment with azathioprine or 6-mercaptopurine for inflammatory bowel disease. The potential risk of combining azathioprine or 6-mercaptopurine with Humira should be carefully considered.).
• There are no studies in patients with a history of malignancy or in whom Humira treatment is continued after the development of cancer. Therefore, increased caution should be observed when considering treatment of these patients with Humira .
• All patients, especially those with a history of intense immunosuppressive therapy or psoriasis and a history of puvathérapie, should be screened for non-melanoma skin cancer before and during treatment with Humira. Cases of melanoma and Merkel cell carcinoma have also been reported in patients treated with anti-TNF including adalimumab .
• In a prospective clinical study evaluating the use of another anti-TNF agent, infliximab, in patients with chronic obstructive pulmonary disease (COPD), moderate to severe, more cancers, mainly lung cancer, were reported. head and neck, among patients treated with infliximab compared to patients in the control group. All patients had a history of heavy smoking. For this reason, care should be taken in the use of TNFα antagonist in patients with COPD, and also in patients at risk of cancer due to heavy smoking.
• Based on current data, it is not known whether adalimumab treatment influences the risk of developing dysplasia or colon cancer. All patients with ulcerative colitis who are at high risk for dysplasia or colon cancer (eg, patients with early bleeding ulcerative colitis or primary sclerosing cholangitis) or who have a history of dysplasia or colon cancer should be referred to regular screening for dysplasia before treatment and throughout the course of their disease. This assessment should include colonoscopy and biopsies according to local recommendations.

Hematologic reactions

Rare cases of pancytopenia including aplastic anemia have been reported with TNF blockers. Undesirable effects of the blood system including medically significant cytopenias (eg thrombocytopenia, leukopenia) have been observed with Humira. All patients should be advised to seek immediate medical attention if they have signs or symptoms suggestive of blood disorders (eg, persistent fever, bruising, bleeding, pallor) under Humira. Discontinuation of Humira should be considered for patients who have significant blood abnormalities confirmed.

immunizations

• Antibody responses similar to the standard 23-valent pneumococcal vaccine and vaccination against trivalent influenza virus were observed in 226 adults with rheumatoid arthritis treated with adalimumab or placebo. There are no data available on the secondary transmission of infection with live vaccines in patients receiving Humira.
• In children and adolescents, it is recommended, if possible, that all vaccinations be up-to-date in accordance with the vaccination recommendations in force before the start of treatment with Humira.
• Humira patients can receive multiple vaccines simultaneously, except for live vaccines. The administration of live vaccines to infants who have been exposed to adalimumab in utero is not recommended for 5 months following the last injection of adalimumab into the mother during pregnancy.

Congestive heart failure

• In a clinical trial with another TNF antagonist, aggravation of congestive heart failure and increased mortality from congestive heart failure were observed. Cases of aggravation of congestive heart failure have also been reported in patients taking Humira. 
• Humira should be used with caution in patients with mild heart failure (NYHA Class I / II). 
• Humira is contraindicated in moderate to severe heart failure.
• Humira treatment should be discontinued in patients with new or worsening symptoms of congestive heart failure.

Autoimmune processes

• Humira treatment may result in the formation of autoimmune antibodies.
• The impact of long-term Humira treatment on the development of autoimmune diseases is unknown. If a patient develops symptoms suggestive of lupus syndrome following Humira treatment and has a positive anti-double-stranded DNA reaction, treatment with Humira should not be continued .

Simultaneous administration of biological DMARDs or TNF antagonists

• Serious infections have been observed in clinical studies when simultaneous administration of anakinra and another TNF-antagonist, etanercept, did not provide additional clinical benefit compared with etanercept alone. Due to the nature of the adverse effects observed with etanercept and anakinra combination therapy, similar adverse effects may also result from the combination of anakinra and other TNF antagonists.Therefore the combination of adalimumab and anakinra is not recommended (see section Interactions with other medicinal products and other forms of interaction ).
• Concomitant administration of adalimumab with other biological DMARDs (eg anakinra and abatacept) or other TNF antagonists is not recommended because of the potential increase in the risk of infections, including serious infections, and other potential pharmacological interactions.

Surgery

• Experience with tolerance during surgical procedures in patients treated with Humira is limited.
•  The long half-life of adalimumab should be taken into account if surgery is planned. A Humira-treated patient requiring surgery should be carefully monitored for infections and appropriate actions should be undertaken.
• Experience with Humira tolerance in patients undergoing arthroplasty is limited.

Occlusion of hail

• In Crohn’s disease, treatment failure may indicate the presence of fixed fibrotic stenoses that may require surgical treatment. Available data suggest that Humira does not worsen or cause stenosis.

Elderly

The frequency of serious infections in Humira treated subjects over 65 years (3.7%) is higher than in patients younger than 65 years (1.5%). 

Some cases have had a fatal outcome. Special attention to the risk of infection should be given when treating elderly subjects.

Pediatric population

See Vaccinations above.

Drive and use machines

Humira may have a minor influence on the ability to drive and use machines. Vertigo and visual disturbances may occur after administration of Humira.

Humira and PREGNANCY / BREAST FEEDING / FERTILITY

Women of childbearing age, contraception in men and women

It is strongly recommended that women of childbearing potential use an effective method of contraception while taking Humira and continue for at least five months after the last Humira administration.

humira injection and pregnancy

• For Humira, there is limited data on the use of this drug in pregnant women.
• In a developmental toxicity study in monkeys, there was no evidence of maternal toxicity, embryo-toxicity, or teratogenic potential. There are no preclinical data on the postnatal toxicity of adalimumab.
• Because of its inhibitory effect on TNFα, adalimumab administered during pregnancy may affect the normal immune responses of the newborn. Administration of adalimumab is not recommended during pregnancy.
• In women who take adalimumab during pregnancy, adalimumab can cross the placenta and pass into their child’s blood. As a result, these children may have an increased risk of infections.
•  The administration of live vaccines to children who have been exposed to adalimumab in utero is not recommended for 5 months following the mother’s last injection during pregnancy.

feeding

• It is not known whether adalimumab is excreted in breast milk or passes into the systemic circulation after administration.
• However, since human immunoglobulins pass into breast milk, women should not breastfeed for at least five months after the last Humira administration.

Fertility

• There are no preclinical data on the effects of adalimumab on fertility.

What should I do if I miss a dose?

You usually use this medication once every 2 weeks. In some cases you use this medicine once a week: give the forgotten dose as soon as you remember.

Take the next dose on the normal day of the administration schedule.

What happens if I overdose from Humira ?

No dose-related toxicity was observed in the clinical trials. The highest dose evaluated was repeated doses of 10 mg / kg IV, which is approximately 15 times the recommended dose.

What is  Forms and Composition?

• Solution for injection (clear, colorless) 40 mg SC:  0.4 ml pre-filled single-dose syringes + 1 alcohol swab, box of 2, in blister pack.
• Pre-filled single-dose pens of 0.4 ml + 1 alcohol swab, box of 2, under blister. Solution for injection (clear, colorless) SC for pediatric use at 40 mg / 0.8 ml: 0.8 ml   vials for single use + 1 sterile syringe for injection + 1 needle + 1 adapter for vial + 2 alcohol swabs, box of 2.

NOT’s

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• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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