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Golimumab Dosage

Applies to the following strength(s): 50 mg/0.5 mL ; 100 mg/mL ; 50 mg/4 mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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.

Uses:
-Psoriatic Arthritis: For the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate
-Ankylosing Spondylitis: For the treatment of adult patients with active ankylosing spondylitis

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.

Uses:
-Psoriatic Arthritis: For the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate
-Ankylosing Spondylitis: For the treatment of adult patients with active ankylosing spondylitis

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

Use: Ulcerative Colitis: For treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had 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

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.

Use: Rheumatoid Arthritis: For the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
SERIOUS INFECTIONS AND MALIGNANCY:
-SERIOUS INFECTIONS: Patients treated with this drug are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue therapy if a patient develops a serious infection.
REPORTED INFECTIONS WITH TNF-BLOCKERS, SUCH AS THIS DRUG, INCLUDE:
-Active tuberculosis (TB), including reactivation of latent TB: Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before therapy initiation and during therapy. Initiate treatment for latent TB prior to therapy.
-Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis: Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
-Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
-Consider the risks and benefits of treatment with this drug prior to initiating therapy in patients with chronic or recurrent infection.
-Monitor patients closely for the development of signs of infection during and after treatment, including the possible development of TB in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
MALIGNANCY:
-Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers.

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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