Adalimumab Humira

What is adalimumab (Humira), and what is it used for?

Rheumatoid Arthritis

Humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Humira can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

Psoriatic Arthritis

Humira is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. Humira can be used alone or in combination with DMARDs.

Ankylosing Spondylitis

Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn’s Disease

Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Plaque Psoriasis

Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

What are the side effects of adalimumab (Humira)?

Serious side effects, which sometimes lead to death, have happened in patients taking Humira, including:

• Serious infections.

Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. Patients who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:

• cough that does not go away
• low grade fever
• weight loss
• loss of body fat and muscle (wasting)
• Certain types of Cancer.
• There have been cases of certain kinds of cancer, in patients taking Humira or other TNF blockers.
• Some patients receiving Humira have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn't heal.
• Patients with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• Allergic reactions. Signs of a serious allergic reaction include a skin rash, a swollen face, or trouble breathing.

Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with Humira if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms:

• feel unwell
• poor appetite
• tiredness (fatigue)
• fever, skin rash, or joint pain
• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• New heart failure or worsening of heart failure you already have. Symptoms include shortness of breath or swelling of your ankles or feet or sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may go away when you stop Humira.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.
Common side effects with Humira include:

• Injection site reactions such as redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. If you have pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse, call your doctor right away.
• Upper respiratory infections (including sinus infections)
• Headaches
• Rash
• Nausea

These are not all the possible side effects with Humira. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.

What is the dosage for adalimumab (Humira)?

Humira is administered by subcutaneous injection.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dose of Humira for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other DMARDs may be continued during treatment with Humira. In rheumatoid arthritis, some patients not taking concomitant methotrexate may derive additional benefit from increasing the dosing frequency of Humira to 40 mg every week.

Crohn’s Disease

The recommended Humira dose regimen for adult patients with Crohn’s disease is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., 6mercaptopurine and azathioprine) may be continued during treatment with Humira. The use of Humira in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

Plaque Psoriasis

The recommended dose of Humira for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of Humira in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.

General Considerations for Administration

Humira is intended for use under the guidance and supervision of a physician. A patient may self-inject Humira if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
The solution in the Humira Pen or prefilled syringe should be carefully inspected visually for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, the product should not be used. Humira does not contain preservatives; therefore, unused portions of drug remaining from the syringe should be discarded. NOTE: The needle cover of the syringe contains dry rubber (latex), which should not be handled by persons sensitive to this substance.
Patients using the Humira Pen or prefilled syringe should be instructed to inject the full amount in the syringe (0.8 mL), which provides 40 mg of Humira.
Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red or hard.

Dosage Forms and Strength

Pen

A single-use pen (Humira Pen), containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

Prefilled Syringe

A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.

What drugs interact with adalimumab (Humira)?

Anakinra

Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF-blocking agent has been associated with an increased risk of serious infections, an increased risk of neutropenia and no additional benefit compared to these medicinal products alone. Therefore, the combination of anakinra with other TNF-blocking agents, including Humira, may also result in similar toxicities.

Live Vaccines

Live vaccines should not be given concurrently with Humira.

Methotrexate

Humira has been studied in rheumatoid arthritis patients taking concomitant methotrexate. Although methotrexate reduced the apparent adalimumab clearance, the data do not suggest the need for dose adjustment of either Humira or methotrexate.

Is adalimumab (Humira) safe to take if I'm pregnant or breastfeeding?

Pregnancy

Pregnancy Category B - An embryo-fetal perinatal developmental toxicity study has been performed in cynomolgus monkeys at dosages up to 100 mg/kg (266 times human AUC when given 40 mg subcutaneously with methotrexate every week or 373 times human AUC when given 40 mg subcutaneously without methotrexate) and has revealed no evidence of harm to the fetuses due to adalimumab. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction and developmental studies are not always predictive of human response, Humira should be used during pregnancy only if clearly needed.
Pregnancy Registry: To monitor outcomes of pregnant women exposed to Humira, a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-877-311-8972.

Nursing Mothers

It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Humira, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

What else should I know about adalimumab (Humira)?

Humira (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (Humira Pen) or as a single-use, 1 mL prefilled glass syringe. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of Humira is clear and colorless, with a pH of about 5.2. Each syringe delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Humira contains 40 mg adalimumab, 4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate,
1.04 mg citric acid monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80, and Water for Injection, USP. Sodium hydroxide added as necessary to adjust pH.

How does adalimumab (Humira) work?

Humira (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (Humira Pen) or as a single-use, 1 mL prefilled glass syringe. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of Humira is clear and colorless, with a pH of about 5.2. Each syringe delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Humira contains 40 mg adalimumab, 4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate,
1.04 mg citric acid monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80, and Water for Injection, USP. Sodium hydroxide added as necessary to adjust pH.

Summary

Humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis and other inflammatory conditions like psoriasis and Crohn's. Humira can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).