Precautions
Can I stop taking SIMPONI?
You may have to stop Golimumab while being treated for an infection. You may also have to stop if you are planning a surgery. You will need to have a negative tuberculosis (TB) skin test before beginning Golimumab therapy.
Does SIMPONI cause liver damage?
There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF blockers.
Does SIMPONI weaken immune system?
SIMPONI is a medicine that affects your immune system. SIMPONI can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body.
How often can you take SIMPONI?
After these 3 starter injections, SIMPONI® requires one 100-mg injection every 4 weeks. Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI® under the skin.
What are the long term side effects of Simponi?
Serious side effects of Simponi and Simponi AriaBlood disorders, including decreased levels of white blood cells or neutrophils (a type of white blood cell). ... Heart failure, which can cause sudden weight gain and other symptoms, such as: ... Lupus-like syndrome (a type of immune system reaction).More items...•
Is weight gain a side effect of Simponi?
It's also important to note that methotrexate (Trexall, Otrexup), a medication sometimes prescribed with Simponi or Simponi Aria, can cause weight gain. Weight gain can also be related to symptoms of the conditions these drugs are prescribed to treat, such as rheumatoid arthritis.
Does SIMPONI cause fatigue?
FDA expands Simponi Aria labeling to include fatigue in RA, PsA.
Does SIMPONI cause depression?
In clinical trials, serious depression including suicidality has been reported in patients treated with SIMPONI.
Can you drink alcohol while on SIMPONI?
Alcohol. There's no known interaction between golimumab and alcohol, so it's fine to have a drink if you're taking this medication.
How much is a SIMPONI injection?
GOLIMUMAB is used to treat rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis. It is also used to treat ulcerative colitis. The lowest GoodRx price for the most common version of Simponi is around $5,423.76, 31% off the average retail price of $7,934.31.
Can you take ibuprofen with SIMPONI?
Interactions between your drugs No interactions were found between ibuprofen and Simponi Aria.
What class is SIMPONI?
Simponi belongs to a class of drugs called Antipsoriatics, Systemic; DMARDs, TNF Inhibitors; Monoclonal Antibodies; Inflammatory Bowel Disease Agents.
Can you drink alcohol while on Simponi?
Alcohol. There's no known interaction between golimumab and alcohol, so it's fine to have a drink if you're taking this medication.
What are the side effects of golimumab?
Less commonBleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.burning or stinging of the skin.More items...•
How long has Simponi Aria been on the market?
Simponi Aria was originally approved in 2013 for the treatment of moderate-to-severe active rheumatoid arthritis. This new approval was based on data from 2 large-scale pivotal phase 3 trials that demonstrated significant improvements in signs and symptoms of PsA and AS in adult patients compared with placebo.
Does Simponi cause fatigue?
FDA expands Simponi Aria labeling to include fatigue in RA, PsA.
Before Taking This Medicine
You should not use Simponi if you are allergic to golimumab.Tell your doctor if you have ever had tuberculosis, if anyone in your household has tub...
How Should I Use Simponi?
Use Simponi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sh...
Simponi Dosing Information
Usual Adult Dose for Ankylosing Spondylitis:Initial dose: 50 mg subcutaneously once a monthComments:-Psoriatic arthritis or ankylosing spondylitis:...
What Happens If I Miss A Dose?
Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use two doses at one time.
What Should I Avoid While Using Simponi?
Do not receive a "live" vaccine while using Simponi, and avoid coming into contact with anyone who has recently received a live vaccine. There is a...
What Other Drugs Will Affect Simponi?
Tell your doctor about all your other medicines, especially: 1. anakinra; 2. abatacept, etanercept; or 3. adalimumab, certolizumab, infliximab, rit...
Indications and Usage For Simponi
This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis).
May Treat: Ankylosing spondylitis · Polyarticular juvenile idiopathic arthritis · Psoriatic arthritis · Rheumatoid arthritis · Ulcerative colitis
Drug Class: Anti-inflammatory Tumor Necrosis Factor Inhibiting Agnts, TNF-alpha Sel · DMARD - Anti-inflammatory Tumor Necrosis Factor Inhibiting Agents · Inflammatory Bowel Agent - Tumor Necrosis Factor Alpha Blockers
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
May Treat: Ankylosing spondylitis · Polyarticular juvenile idiopathic arthritis · Psoriatic arthritis · Rheumatoid arthritis · Ulcerative colitis
Drug Class: Anti-inflammatory Tumor Necrosis Factor Inhibiting Agnts, TNF-alpha Sel · DMARD - Anti-inflammatory Tumor Necrosis Factor Inhibiting Agents · Inflammatory Bowel Agent - Tumor Necrosis Factor Alpha Blockers
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: JANSSEN BIOTECH
- Check for TB before and during treatment
- The drug may increase the risk of getting cancer.
- For pen injector products : Call MD now for fever, chills, cough or fatigue. Important to read patient package insert & med guide. Rotate under-the-skin sites of injections. Do not shake this medicine. Call MD immediately for changes in your condition. Store in the refrigerator Do not freeze.
- Check for TB before and during treatment
- The drug may increase the risk of getting cancer.
- For pen injector products : Call MD now for fever, chills, cough or fatigue. Important to read patient package insert & med guide. Rotate under-the-skin sites of injections. Do not shake this medicine. Call MD immediately for changes in your condition. Store in the refrigerator Do not freeze.
- For vial products : Before use, important to read the Medication Guide. Drug is given by a nurse or a doctor. Avoid infections and recently immunized people. Call MD if fatigue/sore throat/infection occurs. Call Dr. if numbness or yellowing of skin occur. Tell doctor your complete medical history.
Simponi Dosage and Administration
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
Drug Interactions
- Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
The Simponi dose regimen is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), Simponi should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), Simponi may be giv… - 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.
Use in Specific Populations
- Injection: 50 mg/0.5 mL and 100 mg/mL clear to slightly opalescent, colorless to light yellow solution in a single-dose prefilled syringe or single-dose SmartJect autoinjector.
Overdosage
- Serious Infections
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. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including … - Malignancies
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. Approximately half the cases were lymphomas, including Hodgkin's and n…
Simponi Description
- Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data describ… - Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be in…
Simponi - Clinical Pharmacology
- Methotrexate
For the treatment of RA, Simponi should be used with methotrexate (MTX) [see Clinical Studies (14.1)]. Since the presence or absence of concomitant MTX did not appear to influence the efficacy or safety of Simponi in the treatment of PsA or AS, Simponi can be used with or withou… - Biological Products for RA, PsA, and/or AS
An increased risk of serious infections has been seen in clinical RA trials of other TNF blockers used in combination with anakinra or abatacept, with no added benefit; therefore, use of Simponi with abatacept or anakinra is not recommended [see Warnings and Precautions (5.6, 5.7)]. A hig…