SIMPONI Injection
Golimumab
50mg/0.5ml
CILAG AG
| Pack size | 0.5ml Pre-filled Pen |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 5561.00 AED |
Available as:
Indications
SIMPONI Injection is used for:
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis
Adult Dose
Rheumatoid Arthritis
Indicated for moderately-to-severely active rheumatoid arthritis in combination with methotrexate
SC solution: 50 mg SC qMonth
IV solution: 2 mg/kg IV at weeks 0 and 4, then q8Weeks
Psoriatic Arthritis
Indicated for moderately-to-severely active rheumatoid arthritis in combination with methotrexate
SC solution
50 mg SC qMonth
IV solution
2 mg/kg IV at weeks 0 and 4, then q8Weeks
Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment
Ankylosing Spondylitis
Indicated for active ankylosing spondylitis with or without methotrexate
SC solution
50 mg SC qMonth
IV solution
2 mg/kg IV at weeks 0 and 4, then q8Weeks
Corticosteroids, NSAIDs, and/or analgesics may be continued during treatment
Ulcerative Colitis
SC solution
Indicated in adults with moderate to severe active ulcerative colitis who demonstrate corticosteroid dependence or who have an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, achieving and sustaining clinical remission in induction responders
Initial: 200 mg SC at Week 0, followed by 100 mg SC at Week 2, THEN
Maintenance: 100 mg SC q4Weeks
Child Dose
Renal Dose
Renal impairment
No formal trial of the effect of renal or hepatic impairment on pharmacokinetics was conducted
Administration
IV Preparation
Inspect vial; solution is colorless to light yellow and opalescent
Do not use if opaque particles, discoloration or other foreign particles are present
Dilute calculated dose volume with 0.9% NaCl to a final volume of 100 mL; alternatively, 0.45% NaCl Injection, USP can also be used; gently mix (DO NOT SHAKE)
Discard any unused drug remaining in the vials
IV Administration
Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.22 micrometer or less)
Do not administer concomitantly in same IV line with other agents
Infuse over 30 minutes
SC Administration
Warm by sitting at room temperature for 30 min; do NOT heat or microwave
If multiple injections required, administer at different site on the body
Injection sites: Front of thighs (recommended), lower abdomen (except for a 2-inch area right around the navel); back of the upper arms (only if someone else is administering it)
Rotate injection sites for each administration
Do not administer in area where the skin is tender, bruised, red, or hard
Contra Indications
Precautions
Risk of infections, reactivation of latent hepatitis/TB; interrupt if serious infection develops (eg, bacterial sepsis, severe invasive fungal infections, opportunistic infections)
Risk of exacerbation of or new onset heart failure; discontinue therapy if worsening symptoms occur; fatal outcomes reported in patients with congestive heart failure
Pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia may occur; exercise caution when using TNF-blockers in patients who have or have had significant cytopenias
Use of TNF-blockers, including golimumab, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders (eg, multiple sclerosis [MS]) and peripheral demyelinating disorders (eg, Guillain Barre syndrome)
Treatment with TNF blockers, including golimumab, may result in the formation of antinuclear antibodies (ANA); rarely, treatment with TNF blockers, may result in the development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, discontinue treatment
Serious systemic hypersensitivity reactions including anaphylaxis may occur
Severe hepatic reactions including acute liver failure in patients receiving TNF blockers reported
Malignancies
Increased risk of lymphoma and other cancers reported in children and adolescents
Occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers
Skin cancer (melanoma, Merkel cell carcinoma) reported with TNF blockers; perform periodic skin examination for all patients, particularly those with risk factors for skin cancer
Hepatosplenic T-cell lymphomas (HSTCL)
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled trials in pregnant women; monoclonal antibodies are transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant
Use during pregnancy only if clearly needed
Clinical considerations
Golimumab crosses the placenta during pregnancy; another TNF-blocking monoclonal antibody administered during pregnancy detected for up to 6 months in serum of infants; consequently, infants may be at increased risk of infection
Live vaccines administration to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last dose during pregnancy
Lactation
There is no information regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production
Maternal IgG is known to be present in human milk; the effects of local exposure in gastrointestinal tract and potential limited systemic exposure in the infant to golimumab are unknown; developmental and health benefits of breast-feeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed infants or from the underlying maternal condition
Interactions
Infection risk increases when coadministered with abatacept, anakinra, or rituximab; combination is not recommended
Care should be taken when switching from one biologic product to another biologic product since overlapping biological activity may further increase the risk of infection
May decrease humoral response to live-virus vaccines (eg, MMR)
Administration of live virus vaccines and therapeutic agents (eg, BCG bladder instillation) may result in disseminated infections
Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNF-alpha) during chronic inflammation; molecules (eg, golimumab) that antagonizes cytokine activity may normalize the formation of CYP450 enzymes; upon initiation or discontinuation of treatment in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effects (eg, warfarin) or drug concentrations (eg, cyclosporine or theophylline) is recommended and adjusting individual doses of the drug products as needed
Adverse Effects
Side effects of Golimumab :
>10%
SC solution
Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (16%)
IV solution
Upper respiratory tract infection (eg, upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (12%)
1-10%
SC solution
Injection site reactions (eg, erythema, urticaria, induration, pain, bruising, pruritus, irritation, paresthesia) (6%)
Viral infections (eg, influenza and herpes) (5%)
Increased ALT (4%)
Increased AST (3%)
Dizziness (2%)
Paresthesia (2%)
Bronchitis (2%)
Superficial fungal infections (2%)
Sinusitis (2%)
Constipation (1%)
IV solution
Viral infections (eg, influenza and herpes) (3%)
Hypertension (2%)
Rash (1%)
Pyrexia (1%)
Bronchitis (1%)
Mechanism of Action
Human anti-TNF-alpha monoclonal antibody, binds to both soluble and transmembrane bioactive forms of human TNFα; prevents binding of TNF-alpha to its receptors, thereby inhibiting biological activity of TNFα (a cytokine protein)
Note
SIMPONI 50mg/0.5ml Injection manufactured by CILAG AG. Its generic name is Golimumab. SIMPONI is availble in United Arab Emirates.
Farmaco UAE drug index information on SIMPONI Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.