Simponi Warnings and Precautions
If you get frequent infections, your healthcare provider may choose not to prescribe Simponi -- this medication has been known to increase the risk of infections. Other warnings and precautions for Simponi apply to people with congestive heart failure, lymphoma, or cancer, among several other conditions. Do not use this product if you are allergic to any of the ingredients used to make it.
What Should I Tell My Healthcare Provider?Prior to using Simponi™ (golimumab), talk to your healthcare provider if you have:
- Congestive heart failure (CHF)
- A history of hepatitis B infection or tuberculosis
- Any current infection
- Infections that come and go, such as cold sores
- Any disease that affects the immune system, such as diabetes, cancer, HIV, or AIDS
- Any conditions that affect the blood, including blood clotting disorders
- Lymphoma or any other type of cancer
- Plans to receive vaccinations
- Multiple sclerosis
- Any allergies, including to food, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant
Make sure to tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medications, vitamins, and herbal supplements.
Some warnings and precautions to be aware of prior to using Simponi include the following:
- Simponi can increase your chance of infections, including serious infections. You should not start using this drug if you have an infection -- even a skin infection. While using it, be sure to tell your healthcare provider right away if you think you may have any infection. Simponi may not be the best choice for people who get frequent infections.
- This medication can cause certain infections, such as hepatitis B or tuberculosis, that have become inactive in the body to become active again. Tell your healthcare provider if you have ever had hepatitis B or tuberculosis before starting Simponi. Your healthcare provider should give you a tuberculosis skin test to make sure you have never had it.
- There have been rare reports of lymphoma (a certain type of cancer) in people using Simponi or other medications similar to it. It is not yet known if Simponi actually caused these cancers or not.
- The needle cover of the prefilled syringes and the autoinjector contain dry natural rubber, which may cause allergic reactions in people with a latex allergy.
- In studies, people with congestive heart failure (CHF) who took medications similar to Simponi had an increased risk of death. Also, worsening of heart failure and new cases of heart failure in people who did not already have it have been reported in people taking such medications. Talk to your healthcare provider about Simponi and congestive heart failure before starting treatment.
- In rare cases, Simponi has caused dangerously low blood counts. You should tell your healthcare provider about any unusual bruising, bleeding, or paleness while using this drug.
- You should not receive live vaccines while using Simponi. Talk to your healthcare provider before receiving any vaccines during treatment.
- In rare cases, Simponi or medications like it have been reported to cause certain nervous system conditions, including multiple sclerosis (MS), optic neuritis, and Guillain-Barré syndrome. Simponi could also make these conditions worse. Talk to your healthcare before beginning treatment if you have MS or any other nervous system condition.
- Simponi can potentially interact with a few other medications (see Simponi Interactions).
- Simponi is considered a pregnancy Category B medication. This means that it is probably safe for use during pregnancy, although the full risks are not currently known (see Simponi and Pregnancy).
- It is not known if Simponi passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Simponi and Breastfeeding).