Adalimab
Generic Name
Adalimab-40-mg-injection
Manufacturer
Global Biopharma (various biosimilar manufacturers)
Country
Multiple countries
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| adalimab 40 mg injection | ৳ 15,000.00 | N/A |
Description
Overview of the medicine
Adalimab 40 mg injection (generic name Adalimumab) is a biologic medicine that modulates the immune system. It targets and blocks Tumor Necrosis Factor-alpha (TNF-alpha), a protein involved in inflammatory processes. It is used to treat various autoimmune conditions such as rheumatoid arthritis, Crohn's disease, psoriasis, and ulcerative colitis.
Uses & Indications
Dosage
Adults
For most indications, 40 mg administered subcutaneously every other week. Some conditions may require an initial loading dose (e.g., 160 mg on Day 1, then 80 mg on Day 15 for Crohn's Disease).
Elderly
No specific dose adjustment is required, but caution should be exercised due to a higher incidence of infections in the elderly population.
Renal_impairment
No dose adjustment is necessary for patients with renal impairment.
How to Take
Administer by subcutaneous injection. Patients should be trained by a healthcare professional on proper injection technique before self-administration. Injection sites should be rotated.
Mechanism of Action
Adalimab (Adalimumab) is a recombinant human IgG1 monoclonal antibody that specifically binds to soluble and transmembrane TNF-alpha, blocking its interaction with p55 and p75 cell surface TNF receptors. This prevents TNF-alpha-mediated cellular responses, reducing inflammation.
Pharmacokinetics
Onset
Clinical response typically observed within weeks, with full therapeutic effect often taking several months.
Excretion
Elimination of adalimumab is predominantly via catabolism, with no specific excretion pathway identified.
Half life
Approximately 10-20 days (range 10 to 20 days), allowing for bi-weekly dosing.
Absorption
Slow subcutaneous absorption. Peak serum concentration is reached approximately 5 days after a single subcutaneous dose. Bioavailability is approximately 64%.
Metabolism
As a protein, it is primarily catabolized by the reticuloendothelial system into small peptides and amino acids, rather than undergoing CYP450 metabolism.
Side Effects
Contraindications
- Active serious infections (e.g., tuberculosis, sepsis, opportunistic infections)
- Moderate to severe heart failure (NYHA class III/IV)
- Hypersensitivity to adalimab or any of its excipients
Drug Interactions
Anakinra
Increased risk of serious infection and neutropenia; concomitant use is not recommended.
Abatacept
Increased risk of serious infection; concomitant use is not recommended.
Live vaccines
Avoid co-administration, as TNF blockers may increase the risk of infection.
Natalizumab or Rituximab
Caution is advised due to potential increased immunosuppression.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Once removed from the refrigerator, it may be stored at room temperature (up to 25°C/77°F) for a specific period (check product leaflet, typically 14-30 days) but must not be returned to the refrigerator.
Overdose
No dose-limiting toxicity was observed during clinical trials. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Adalimumab is known to cross the placenta. Limited data suggest minimal transfer into breast milk; however, advise breastfeeding women to monitor for signs of infection in the infant.
Side Effects
Contraindications
- Active serious infections (e.g., tuberculosis, sepsis, opportunistic infections)
- Moderate to severe heart failure (NYHA class III/IV)
- Hypersensitivity to adalimab or any of its excipients
Drug Interactions
Anakinra
Increased risk of serious infection and neutropenia; concomitant use is not recommended.
Abatacept
Increased risk of serious infection; concomitant use is not recommended.
Live vaccines
Avoid co-administration, as TNF blockers may increase the risk of infection.
Natalizumab or Rituximab
Caution is advised due to potential increased immunosuppression.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Once removed from the refrigerator, it may be stored at room temperature (up to 25°C/77°F) for a specific period (check product leaflet, typically 14-30 days) but must not be returned to the refrigerator.
Overdose
No dose-limiting toxicity was observed during clinical trials. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Pregnancy & Lactation
Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Adalimumab is known to cross the placenta. Limited data suggest minimal transfer into breast milk; however, advise breastfeeding women to monitor for signs of infection in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when stored correctly (check specific product label)
Availability
Worldwide
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent expired in many regions, biosimilars available
WHO Essential Medicine
YesClinical Trials
Adalimumab has undergone extensive clinical trials demonstrating its efficacy and safety across multiple indications, including rheumatoid arthritis, Crohn's disease, psoriasis, and other autoimmune conditions, establishing it as a cornerstone biologic therapy.
Lab Monitoring
- Tuberculosis (TB) screening (before initiation and periodically during therapy)
- Hepatitis B Virus (HBV) screening (before initiation)
- Complete Blood Count (CBC) with differential
- Liver function tests (LFTs)
- C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) to monitor disease activity
Doctor Notes
- Screen patients for latent TB and HBV infection prior to initiating and during therapy.
- Monitor for signs and symptoms of infection throughout treatment, and discontinue if a serious infection develops.
- Inform patients about the potential risk of malignancies, including lymphoma.
- Caution in patients with a history of recurrent infections or underlying conditions predisposing to infection.
- Assess cardiac function in patients with pre-existing heart failure.
Patient Guidelines
- Learn and practice proper self-injection technique as instructed by your healthcare provider.
- Report any signs of infection (fever, persistent cough, skin lesions) immediately to your doctor.
- Avoid live vaccines while on adalimab therapy.
- Keep all scheduled appointments with your doctor and for lab monitoring.
- Store the medicine properly as advised.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered if within a few days, then resume the regular schedule. If it is almost time for the next scheduled dose, skip the missed dose and continue with the regular schedule. Do not double the dose.
Driving Precautions
Adalimab is not known to directly affect the ability to drive or operate machinery. However, if you experience side effects that might impair your concentration or reaction time (e.g., dizziness, vision changes), you should avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, as advised by your doctor.
- Avoid close contact with people who have infections.
- Inform all healthcare providers about your adalimab treatment before any procedures or new medications.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.