Mabura 40mg (Adalimumab)

DESCRIPTION

Adalimumab is belonging to the class of tumor necrosis factor inhibitor, anti-inflammatory, or biologic drug. Mabura has 40mg of Adalimumab which is human IgG1monoclonal antibody especially for tumor necrosis factor TNF

Mabura 40mg/0.8ml containing an active ingredient Adalimumab is a FDA product involved in the therapy of rheumatoid arthritis, chronic plaque psoriasis, crohn’s disease, Ankylosing spondylitis, psoriatic arthritis & polyarticular juvenile idiopathic arthritis.

INDICATION

Mabura consist of Adalimumab, exist as anti-inflammatory agent. Mabura categorized as; Anti-inflammatory TNF inhibitors Biologic medication Immuno suppressive agent Mabura is involved in the treatment of auto immune disease like rheumatoid arthritis.

In rheumatoid arthritis RA:
Mabura is used to diminish the manifestation related to rheumatoid arthritis in adults, it also exhibits effect in serious polyarticular juvenile idiopathic arthritis with the age of 4 years or older. In this condition, Mabura is used in combination with methotrexate.

In psoriasis arthritis PA:
Mabura is used in psoriasis arthritis

In Ankylosing spondylitis AS:
Mabura is used to reduce the syndrome of AS Various conditions like crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and juvenile idiopathic arthritis.

MECHANISM OF ACTION

Tumor necrosis factor is a naturally arising cytokine, which involved in natural inflammatory and immune reaction. Increased level of tumor necrosis factor which is occurs in synovial fluid of rheumatoid arthritis patients. This elevation level leads to cause pathological inflammation and joint eradication.

Mabura contains Adalimumab exhibits action by definitely binds to TNF-alpha and involved in blockade of inter communication of TNF alpha with its receptors like p55 & p75 cell surface receptors. Mabura also sophisticated in lyses of surface TNF disclose cells in vitro in the presence of completion.

ADME PROPERTIES

The peak plasma concentration time of Mabura is occurs at 131 ± 56 hours and maximum serum concentration is 4.7 ± 1.6mcg/ml The mean bioavailability of Mabura is reaches at 64% The volume of distribution is 4.7 to 6.0L

The systemic clearance of Adalimumab is relatively occurs as 12ml/hr The mean terminal half life period of Adalimumab is relatively occurs as 2 weeks ranging from 10 to 20 days

DOSAGE MANAGEMENT

MABURA DOSAGE MANAGEMENT AND ADMINISTRATION

In RA, PA, & AS
The usual recommended dosage of Mabura in these conditions, 40mg should be administered for every other week through subcutaneously. Other medicines like methotrexate, NSAIDS, glucocorticoid, salicylates, analgesics, or DMARDs may be carrying out during the therapy with Exemptia. In some patients, methotrexate is not used for combination. In this condition the dosage frequency of Mabura is elevates to 40mg for every week.

In juvenile idiopathic arthritis
The usual dose of Mabura is recommended for the age of 4 to 17 years with polyarticular JIA is calculated on the basis of body weight of the patients. Methotrexate, NSAIDS, glucocorticoid, salicylates or analgesics may be used in combination. In 10kg to less than 15kg: 10mg dose should be used In 15 kg to <30kg: 20mg of dose for every other week ≥30kg: 40mg of dose for every other week

In adult crohn’s
In this conditions, the recommended dosage of Mabura is 160mg starting at day 1 (administered as four 40mg in a day or two 40mg per day for two successive days) proceeding with 80mg two weeks later (day 15). After two weeks, day 29 starts with continuance dose of 40mg every other week. Aminosalicylates, corticosteroids, or Immuno modulatory agents may be used during the therapy.

For pediatrics
6 years & older: 17kg to less than 40kg: The initial dose is 80mg given subcutaneous on day 1 followed by 40mg two weeks later, then 20mg SC every other week 40kg or greater: 160mg of Mabura given subcutaneous on day 1, respectively 80mg SC for two weeks later, then 40mg SC every other week.

In ulcerative colitis
The recommended dosage of Mabura is 160mg starting at day 1 (administered as four 40mg in a day or two 40mg per day for two successive days) proceeding with 80mg two weeks later (day 15). After two weeks, day 29 starts with continuance dose of 40mg every other week.

Plaque psoriasis
The recommended dosage of Mabura is starting with 80mg, which is followed by 40mg for every other week, initiate one week after the initial dose

How to take Exemptia
Mabura is a prefilled syringe, single use. Mabura is administered through subcutaneous; with maintenance therapy at every week

SIDE EFFECTS

MABURA CAUSING SIDE EFFECTS
Severe infections Malignancies, Erythema, Itching, Hemorrhage, Pain, swelling, Rash, Pneumonia, Tuberculosis, Lupus like syndrome, Sinusitis, Flu like syndrome, Respiratory tract infection, Abdominal pain, Nausea, Hypercholesterolemia, Hyperlipidaemia, Hematuria, Elevation of alkaline phosphatase, Injection site pain, Headache, Back pain, Hypertension, Thrombocytopenia, Anaphylaxis, Angioneurotic edema, Interstitial lung disease like pulmonary fibrosis, Cutaneous vasculitis, psoriasis, Erythema multiforme, Systemic vasculitis

PRECAUTION

MABURA PRECAUTIONS
To reduce the serious infections, avoid concomitant use of Mabura with methotrexate, Anakinra etc Before starting the therapy, patient should be examine whether presence or absence of tuberculosis in active or latent stage. Mabura therapy should not be recommended for the patients who are infected with active tuberculosis.

Risk takes into consideration while starting the therapy;
1. Severe or frequent infection
2. Patient exposed to tuberculosis
3. With the history of an opportunistic infection
4. With viral, fungal or bacterial infections

Patients should be frequently monitored, the signs and manifestation of tuberculosis The exposure and advantages of TNF-inhibitor therapy including Mabura should be taken into consideration, before initiation of therapy. To reduce the risk of non-melanoma skin cancer or other malignancy In pediatric patients, Hepatosplenic T-cell lymphoma occurs during the TNF blocking therapy, this may occur due to combination of TNF blocker with other immunosuppressant Post marketing hypersensitivity reactions occurs like anaphylaxis, angioneurotic edema and other allergic conditions may occur. In this condition Mabura should be discontinue and provide alternative medicine.

HBV reactivation occurs
Neurological reactions
Hematological reactions

While using with anakinra causes severe adverse reaction related to anakinra, avoid this concomitant Autoimmunity occurs during the therapy with Mabura , lupus like syndrome occurs Immunizations, concurrent usage of Mabura with live vaccine should be avoided While using abatacept with Mabura causes serious infections, use Mabura alone.

MABURA WARNING

During the therapy with Mabura , some serious infections may occur; Increased exposure of infections
Active tuberculosis
Invasive fungal infections like histoplasmosis, coccidioidomycosis, candidiasis, blastomycosis etc.
Viral and bacterial infections
Lymphomas and other malignancy
Hepatosplenic T-cell lymphoma

DRUG INTERACTION

If Adalimumab combines with anakinra (interleukin 1 antagonist), or other TNF blocking agents may have increased the risk of adverse effects like neutropenia. Avoid the combination of Mabura with Anakinra. Mabura increase the adverse effects of Anakinra Live vaccines should not be concomitant during the therapy using with Mabura In rheumatoid arthritis, Mabura is combined with methotrexate causes depleting the apparent clearance of Exemptia

CONTRAINDICATION

No contraindication occurs in the therapy. Some anaphylactic reactions may occur, if patients are contraindicated to the component present in the product Mabura Severe infection like sepsis, tuberculosis occurs Moderate to serious heart failure occurs.

PREGNANCY

Pregnancy category: C Mabura should not be recommended in pregnancy condition; placental transformation is applicable Mabura used if it is necessary only getting advice from medical practitioner

LACTATION

Breast feeding should not be recommended

STORAGE

Mabura prefilled syringe should be stored at refrigerator condition with the range of 2°C to 8°C (36°F to 46°F). Do not freeze; protect from light Mabura should be store in an original carton until the time of administration. On travelling mode: Mabura should be stored at room temperature at 25°C up to the period of 14 days, must protect from light. If Mabura is not used within 14 days, it should be discarded.

OVER DOSAGE

After acquiring over dosage of Mabura , the manifestation is monitored frequently. The suitable treatment should be provided for the over dosage of Mabura immediately.

MISSED DOSE

Mabura is an Anti-rheumatoid agent, used cautiously If patient fail to take the dose of Mabura must consult with medical adviser and follow the instructions On the other hand, the missed dose should be avoided and maintain the regular dosing schedule.