Golimumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 50 mg subcutaneously once a month

Comments:
-Psoriatic arthritis or ankylosing spondylitis: May be administered with or without methotrexate or other non-biologic Disease Modifying Antirheumatic Drugs (DMARDs).
-RA, PsA or AS: Corticosteroids, non-biologic DMARDs, and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

Usual Adult Dose for Psoriatic Arthritis

Initial dose: 50 mg subcutaneously once a month

Comments:
-Psoriatic arthritis or ankylosing spondylitis: May be administered with or without methotrexate or other non-biologic Disease Modifying Antirheumatic Drugs (DMARDs).
-RA, PsA or AS: Corticosteroids, non-biologic DMARDs, and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

Usual Adult Dose for Ulcerative Colitis

Initial dose: 200 mg subcutaneously at week 0, followed by 100 mg at week 2.
Maintenance dose: 100 mg subcutaneously every 4 weeks.

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 50 mg subcutaneously (SC) once a month or 2 mg per kg intravenous (IV) infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Comments: It should be given in combination with methotrexate. Corticosteroids, non-biologic Disease Modifying Antirheumatic Drugs (DMARDs), analgesics and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

BOXED WARNING(S):
-Serious infections leading to hospitalization or death including tuberculosis, bacterial sepsis, invasive fungal (histoplasmosis), and other opportunistic infections have occurred.
-Discontinue use if a patient develops a serious infection or sepsis.
-Perform test for latent tuberculosis; if positive, start treatment for tuberculosis before starting drug.
-Monitor all patients for active tuberculosis during treatment, even if initial latent tuberculosis test was negative.
-Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which this drug is a member.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Subcutaneous
-Allow the prefilled syringe or auto-injector to reach room temperature for 30 minutes before subcutaneous injection. Do not warm in any other way.
-The solution should not be used if discolored, cloudy, or if foreign particles are present.
-Discard any remaining product.
-If multiple injections are required, rotate administration sites.
-Avoid injection into areas where the skin is tender, bruised, red, or hard.

Intravenous
-Calculate the dosage and the number of vials needed based on the recommended dosage of 2 mg/kg and the patient's weight.
-Check that the solution in each vial is colorless to light yellow.
-Dilute the solution with 0.9% sodium chloride to a final volume of 100 mL.
-Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter.
-Do not infuse concomitantly in the same intravenous line with other drugs.
-Infuse the solution over 30 minutes.

Storage requirements:
-Store in a refrigerator (2C to 8C)
-Do not freeze
-Protect from light
-Do not shake

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