Introduction
Adalimab SC Injection 40 mg/0.8 ml is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. It is primarily used to treat autoimmune diseases like rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. Marketed under the trade name Humira, adalimumab was one of the first fully human monoclonal antibodies approved for therapeutic use.
Uses
Adalimab SC Injection 40 mg/0.8 ml is indicated for the treatment of several chronic inflammatory conditions, including:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Crohn's disease
- Ulcerative colitis
- Hidradenitis suppurativa
- Uveitis
| Brand Name | Adalimab |
|---|---|
| Type | SC Injection |
| Weight | 40 mg/0.8 ml |
| Generic | Adalimumab |
| Manufacturer | Healthcare Pharmaceuticals Ltd. |
| Available in | English বাংলা |
Mechanism of Action
Adalimab SC Injection 40 mg/0.8 ml binds specifically to TNF-α, blocking its interaction with the TNF receptors on the cell surface. This inhibition reduces inflammation and immune responses, which are central to the pathophysiology of various autoimmune diseases. TNF-α is a key player in inflammation, and by neutralizing its action, adalimumab helps mitigate inflammatory symptoms.
How Long Does It Take to Work?
The onset of action of adalimumab can vary depending on the condition being treated. For conditions like rheumatoid arthritis or psoriasis, clinical improvement may be observed within 2-12 weeks of treatment. However, individual response times may differ.
Absorption
Adalimab SC Injection 40 mg/0.8 ml is administered via subcutaneous injection, with an absolute bioavailability of approximately 64%. Peak serum concentrations are typically achieved within 131 hours (approximately 5.5 days).
Route of Elimination
Adalimab SC Injection 40 mg/0.8 ml is metabolized by proteolytic enzymes into small peptides and amino acids. It is not excreted via the kidneys or bile like many small molecules but is broken down primarily in the liver and other tissues.
Dosage
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.Juvenile Idiopathic Arthritis:
- 10 kg to <15 kg: 10 mg every other week
- 15 kg to < 30 kg: 20 mg every other week
- ≥ 30 kg: 40 mg every other week
- Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days).
- Second dose two weeks later (Day 15): 80 mg.
- Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
- For patients with Ulcerative Colitis only: Adalimumab should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
- 17 kg to < 40 kg: Initial dose (Day 1): 80 mg (two 40 mg injections in one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later (Day 29): Maintenance dose of 20 mg every other week.
- ≥ 40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) , Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
- 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
- Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2, Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day), Third (Day 29) and subsequent doses: 40 mg every week.
The dosage of adalimumab varies depending on the condition being treated. Common doses are:
- Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: 40 mg subcutaneously every other week. Some patients not taking concomitant methotrexate may require 40 mg every week.
- Crohn’s Disease and Ulcerative Colitis: An initial dose of 160 mg (administered as four 40 mg injections on Day 1 or as two 40 mg injections daily for two consecutive days), followed by 80 mg two weeks later (Day 15), and 40 mg every other week thereafter.
- Plaque Psoriasis: An initial dose of 80 mg, followed by 40 mg every other week starting one week after the initial dose.
Administration
Adalimab SC Injection 40 mg/0.8 ml is administered as a subcutaneous injection. It is typically injected into the thigh, abdomen, or upper arm, with rotation of injection sites to avoid irritation. Patients can be trained to self-administer the drug at home.
Side Effects
Common side effects include:
- Injection site reactions (pain, redness, swelling)
- Headache
- Nausea
- Upper respiratory infections
- Rash
- Sinusitis
- Urinary tract infections
Toxicity
There is limited data on acute toxicity due to adalimumab overdose, as the drug is a biologic. Symptoms of overdose are generally expected to be similar to those seen with therapeutic use, including immunosuppression and increased risk of infection.
Precautions
Patients should be screened for latent tuberculosis before starting treatment, and monitored for signs of infection during therapy. Adalimab SC Injection 40 mg/0.8 ml should be used with caution in patients with chronic infections, demyelinating diseases, or heart failure. The use of live vaccines should be avoided during treatment.
Interaction
Adalimab SC Injection 40 mg/0.8 ml should not be used in combination with other TNF inhibitors due to increased risk of infections. Caution is advised when used with immunosuppressive agents like methotrexate or corticosteroids, as this can enhance the risk of infection or immune suppression.
Disease Interaction
Adalimab SC Injection 40 mg/0.8 ml may exacerbate conditions like heart failure or increase the risk of demyelinating diseases. Caution should be used in patients with these conditions.
Drug Interaction
There is potential for interaction with other immunosuppressants, particularly those targeting TNF-α or other cytokines. Live vaccines should be avoided during treatment.
Food Interactions
No significant food interactions have been identified with adalimumab. It can be administered without regard to meals.
Pregnancy Use
Adalimab SC Injection 40 mg/0.8 ml is classified as a category B drug for pregnancy, meaning that animal studies have not demonstrated harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation Use
Adalimab SC Injection 40 mg/0.8 ml can be excreted in breast milk, but due to its large molecular weight, the amount that passes into the milk is likely to be low. Caution should be exercised when administering adalimumab to breastfeeding mothers.
Acute Overdose
No specific antidote exists for adalimumab overdose. Management of overdose is primarily supportive, focusing on managing symptoms such as infection or immune-related adverse events.
Contraindication
Adalimab SC Injection 40 mg/0.8 ml is contraindicated in patients with a known hypersensitivity to the drug or any of its components. It is also contraindicated in patients with active infections, including tuberculosis, or those with demyelinating disorders.
Use Direction
Patients should be instructed on proper injection technique and advised to rotate injection sites. The pre-filled syringe or pen should be removed from the refrigerator and allowed to reach room temperature for 15-30 minutes before injection.
Storage Conditions
Adalimab SC Injection 40 mg/0.8 ml should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). It should not be frozen. If needed, adalimumab may be stored at room temperature (up to 25°C/77°F) for up to 14 days, after which it must be discarded.
Volume of Distribution
Adalimab SC Injection 40 mg/0.8 ml has a volume of distribution of approximately 4.7 to 5.5 L, which suggests it is largely confined to the vascular compartment and extracellular space.
Half-Life
The mean half-life of adalimumab is approximately 10 to 20 days. This prolonged half-life is typical of monoclonal antibodies.
Clearance
Adalimab SC Injection 40 mg/0.8 ml has a clearance rate of approximately 12 mL/hr. Clearance can vary based on factors like body weight, the presence of anti-drug antibodies, and concomitant use of immunosuppressants like methotrexate.
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