Drug ID: 1d00000029
Drug Name: Adalimunab
Generic Names: Humira
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: The recommended dose is 40mg to 80 mg, every two weeks; it may be increased if needed.
Juvenile Idiopathic Arthritis- 15 kg (33 lbs) to <30 kg (66 lbs): 20 mg every two weeks ?30 kg (66 lbs): 40 mg every two weeks.
Recommended In: This medication is a tumor necrosis factor alpha (TNF alpha) inhibitor, prescribed for rheumatoid arthritis, crohn's disease (digestive tract inflammation), psoriatic arthritis, ulcerative colitis, plaque psoriasis, ankylosing spondylitis (spine infammation), and juvenile idiopathic arthritis (joint inflammation in children). It blocks the effect of TNF and thereby reduces the inflammation and its consequences in the joints and intestine.
Directions For Use: It comes as a solution to inject under the skin (subcutaneous), by a healthcare provider.
Storage: Refrigerate at 36°F to 46°F (2°C to 8°C) in an airtight container. Do not freeze. Do not use if frozen even if it has been thawed. When traveling, store HUMIRA in a cool carrier with an ice pack. Protect from light.
Dosage Forms: Subcutaneous injection
Side Effects: Serious- Infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body , liver failure, blood clot in the lung, cerebrovascular accident, and cancer.
Most common- Injection site reactions, fever, joint pain, numbness, tingling and swelling in the face, tongue, ankles and lower leg regions, headache, rash, nausea and stomach upset.
Respiratory - Upper respiratory tract infection, asthma, sinusitis and flu syndrome.
Gastrointestinal - Feeling full, loss of appetite, pain in you’re the upper stomach that may spread to the shoulder.
Skin - Redness, rash, itching, bruising and pus filled skin eruptions.
Central Nervous System - Dizziness, confusion and tremor.
Respiratory - Difficulty in breathing.
Heart - Cardiovascular disorder, chest pain and heart attack.
Eye - Vision problems (cataract).
Laboratory Test- High cholesterol in blood, reduced levels of platelets and red cells, blood in urine and increase in the liver enzymes.
Miscellaneous - Accidental injury, back pain, urinary tract infection, weight loss, tiredness and high blood pressure.
In Case of Overdose: Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Avoid If: It may cause serious infection, which leads to death, contact your healthcare provider immediately if you have any signs of infection such as fever, cough, or flu-like symptoms.
Perform lab test for tuberculosis before treatment. Monitor every patient for active tuberculosis while taking this medication.
Tuberculosis treatment should be given prior to this medication.
In some patients it may develop cancer like lymphoma.
Caution should be exercised in patients with cancer, multiple sclerosis, heart disease, during pregnancy and breastfeeding.
Avoid vaccination while taking this medication.
Drug Interaction: Biological Products
In clinical studies in patients with RA, an increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of HUMIRA with abatacept or anakinra is not recommended in patients with RA [see WARNINGS AND PRECAUTIONS]. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of HUMIRA and other biologic products for the treatment of RA, PsA, AS, CD, UC, and Ps. Concomitant administration of HUMIRA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions.
Avoid the use of live vaccines with HUMIRA [see WARNINGS AND PRECAUTIONS].
Cytochrome P450 Substrates
The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNF?, IL-6) during chronic inflammation. It is possible for a molecule that antagonizes cytokine activity, such as adalimumab, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of HUMIRA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.