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Adalimumab

Updated on : May - 2012
Latest prescription information about Adalimumab. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Adalimumab
Pronunciation : a dal aye' mu mab
Therapeutic Classification : Antirheumatics
ICD Code : Y45.4
Trade Name(s): 
International- Humira.
Why it is prescribed (Indications) : 
This medication is a tumor necrosis factor alpha (TNF alpha) inhibitor, prescribed for rheumatoid arthritis, crohn's disease (digestive tract inflammation), psoriatic arthritis, 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. 
When it is not to be taken (Contraindications): 
Hypersensitivity.

Pregnancy Category :

A B C D X
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.

Dosage & When it is to be taken : 
SC- 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.
How it should be taken : 
It comes as a solution to inject under the skin (subcutaneous), by a healthcare provider.
Warnings and Precautions : 
* 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.
Side Effects : 
Serious- Infection, liver failure, blood clot in the lung, cerebrovascular accident, and cancer .
Most common- Injection site reactions, joint pain, numbness, tingling and swelling in the face, tongue, ankles and lower leg regions.
Respiratory - Upper respiratory tract infection, asthma, sinusitis and flu syndrome.
Gastrointestinal - Nausea and abdominal pain.
Skin - Redness, rash, itching, bruising and pus filled skin eruptions.
Central Nervous System - Headache, 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, blood in urine and increase in the liver enzymes.
Miscellaneous - Injection site pain, accidental injury, back pain, urinary tract infection and high blood pressure.
Other Precautions : 
* Avoid vaccination while taking this medication.
Storage Conditions : 
Store it in the refrigerator and in an airtight container. Protect from light. Do not freeze.
♦ Safety Labeling Changes Approved By FDA

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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