Drug Interaction:
Coadminstration of a TNF antagonist and abatacept not recommended
Anakinra - coadminstration of abatacept with anakinra not recommended
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
161. Abatacept powder for injection 250mg/vial 22-07-08
For adult patients with severe active rheumatoid
arthiritis who had an inadequate response to one
more DMARDs such as methotrexate or TNF antagonists
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1. Abatacept Injection 250mg/ml (Addl.Indn.) 10-4-2009
For reducing signs and symptoms of moderately to severe active
polyarticular juvenile idiopathic arthiritis/juvenile rheumatoid
arthiritis in pediatric patients 6 years of age and older who have
had an inadequate response to one or more Dmards such as MTX
2. Abatacept injection 250mg/vial (Addl.Ind.) 20-02-2009
In moderately to severely active rheumatoid arthiritis in adults and
may be used as monotherapy or concomittantly with Dmards other
than TNF antagonists
3. Abatacept powder for injectn.250mg/vial) 22-7-2008
For adults patients with severe rheumatoid arthiritis who have
had an inadequate response to one more Dmards such as
methotrexate or TNF
Adult Theumatoid arthiritis
Juvenile idiopathic arthiritis
Adverse Reaction:
CNS- Dizziness 9%, Headache 16%
Dermatologic - Rash 4%
GI- Dyspepsia 6%
Respiratory - Cough 8%, Nasophryngitis 10%
Miscellaneous- Back pain 7%, Hypertension 7% Pain in extremity 2% urinary tract infectn 6%
Contra-Indications:
Not known
Warnings-
Infections- Excercise caution while using Abatacept in patients with a history of recurrent infections. Discotinue treatment if a patient develops a serious infection
Immunizations- Do not give live vacines concurrently with Abatacept or within 3 months of discontinuation. Abatacept may blunt the efficacy of such immunizations.
Chronic Obstructive pulmonary discease- Adult patients with COPD treated with adatacept developed adverse reactions more freqently. Use adatacept with caution in patients with RA and COPD
Pregnancy- use only if the potential benefit to the mother justifies the potential risk to foetus
Lactation- decide whether to discontinue breast feeding or the drug depending upon the importance of the drug to the mother
Children- Use recommended
Dosages/ Overdosage Etc:
Indication-
Adult Theumatoid arthiritis
Juvenile idiopathic arthiritis
Dosage-
Adult- < 60kg 500mg 2 vials
60 to 100kg 3 vials
> 100kg 4 vials
Patient Information:
1. Inform patients that they should receive abatacept treatment concurrently with a TNF antagonist eg. adalimummab, etanercept, inflixmab, because increased risk of infections
2. Tell your doctor if you expereience any allergic symptoms during the first day after receiving the drug
3. Patients who have a history of recurrent infections, are predisposed and should inform their doctor, if they develop any infection during treatment
4. Vaccines should not given concurrently with adatacept or within 3 months of its discontinuation. Consult your doctor before you start any immunization therapy
5. Inform your doctor if you are pregnant or planning to become pregnant
6. Inform your doctor if you breast feeding your infant
Pharmacology/ Pharmacokinetics:
Pharmacology-
Abatacept a selective costimulation modulator inhibits cell ( T- lymphocyte ) activation by binding to CD 80 and CD 86 therby blocking interaction with CD 28
Pregnancy and lactation:
Pregnancy-
Use with cauion depending upon the importance of the drug to the mother.
Lactation-
Decide whether to discontinue the drug or discontinue nursing the infant depending on the importance of the drug to the mother
Manufacturer Details