Golimumab

What is Golimumab?

• Golimumab (Simponi) is a tumor necrosis factor (TNF) blocker used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Ulcerative colitis.

What are the uses of this medicine?

This medicine is used in adults:

• with the medicine methotrexate to treat moderately to severely active rheumatoid arthritis (RA)
• to treat active psoriatic arthritis (PsA) alone or with methotrexate
• to treat active ankylosing spondylitis (AS)

with moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines:

• to begin helping some of your symptoms.
• in people who respond to Simponi, to get their UC under control (induce remission) and keep UC under control (sustain remission).
• to begin to improve the way the lining of your large intestine looks to your doctor during colonoscopy.

How does this medicine work?

• Golimumab (goe lim’ ue mab) is a human monoclonal immunoglobulin antibody to tumor necrosis factor (TNF) alpha, a proinflammatory cytokine that plays a role in cell injury, inflammation and tissue damage in inflammatory, autoimmune diseases.
• Golimumab is one of several monoclonal antibody inhibitors of TNF and has been shown to be effective in decreasing inflammation and improving symptoms in several autoimmune diseases, including rheumatoid arthritis and ulcerative colitis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Use of Simponi with abatacept or anakinra is not recommended.
• Live vaccines should not be given concurrently with Simponi.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

• The Simponi dose regimen is 50 mg administered by subcutaneous injection once a month.

Dosage in Moderately to Severely Active Ulcerative Colitis

• The recommended Simponi induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.

Administration

• Simponi is given as an injection under the skin (subcutaneous injection).
• If your doctor decides that you or a caregiver may be able to give your injections of Simponi at home, you should receive training on the right way to prepare and inject Simponi. Do not try to inject Simponi yourself until you have been shown the right way to give the injections by your doctor or nurse.
• Use Simponi exactly as prescribed by your doctor. Your doctor will tell you how much Simponi to inject and when to inject it depending on your medical condition.
• Simponi comes in a prefilled syringe or SmartJect autoinjector. Your doctor will prescribe the type that is best for you.
• See the detailed INSTRUCTIONS FOR USE that comes with your Simponi for information about the right way to prepare and give your Simponi injections at home.
• Do not miss any doses of Simponi. If you forget to use Simponi, inject your dose as soon as you remember. Then, take your next dose at your regular scheduled time. In case you are not sure when to inject Simponi, call your doctor or pharmacist.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 50 mg/0.5 mL in a single-dose prefilled syringe or single-dose prefilled SmartJect® autoinjector
• 100 mg/mL in a single-dose prefilled syringe or single-dose prefilled SmartJect® autoinjector

This medicine is available in fallowing brand namesː

• Simponi

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)
• reaction at the site of injection (redness, swelling, itching, pain, bruising, or tingling)
• viral infections such as flu and oral cold sores

Simponi can cause serious side effects, including:

• Serious Infections
• Nervous System Problems
• Immune System Problems
• Liver Problems
• Blood Problems
• Allergic Reactions

What special precautions should I follow?

• Patients treated with Simponi are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Do not start Simponi during an active infection. If an infection develops, monitor carefully, and stop Simponi if infection becomes serious.
• For patients who develop a systemic illness on Simponi, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
• The use of TNF blockers including Simponi has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive). Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Simponi and begin antiviral therapy.
• Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which Simponi is a member. Incidence of lymphoma was greater than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNF blockers.
• Congestive Heart Failure may occur. Worsening, or new onset, may occur. Stop Simponi if new or worsening symptoms occur
• Use of TNF blockers, of which Simponi is a member, has been associated with rare cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS) and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exacerbation or new onset may occur.
• Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including Simponi. Worsening, or new onset, may occur. Stop Simponi if new or worsening symptoms occur.
• Serious systemic hypersensitivity reactions including anaphylaxis may occur.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled trials of Simponi in pregnant women.

Can this medicine be used in children?

• Effectiveness of Simponi in pediatric patients less than 18 years of age has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: golimumab.
• Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sorbitol, and water for injection. Simponi does not contain preservatives.

Who manufactures and distributes this medicine?

• Manufactured by: Janssen Biotech, Inc. Horsham

What should I know about storage and disposal of this medication?

• Refrigerate Simponi at 36°F to 46°F (2°C to 8°C).
• If needed, you may store Simponi at room temperature up to 77°F (25°C) for one period of time up to 30 days.
• Write the date of that you remove Simponi from the refrigerator on the carton.
• If Simponi has reached room temperature, do not put it back in the refrigerator.
• Throw away Simponi if it has been kept at room temperature for 30 days and has not been used.
• Do not freeze Simponi.
• Keep Simponi in the original carton to protect it from light when not being used.
• Do not shake Simponi.
• Do not use Simponi after the expiration date on the carton or on the prefilled syringe or SmartJect autoinjector.
• Keep Simponi and all medicines out of the reach of children.

• Dailymed label info on Golimumab
• FDA Golimumab

Golimumab Resources
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