IMPORTANT SAFETY INFORMATION
Do not take COSELA if you have had a serious allergic reaction to COSELA.
What are the possible serious side effects of COSELA?
- Reactions at the site of injection. Pain, irritation, swollen veins, or blood clots may form at or near the injection site. Signs and symptoms may include swelling, pain, redness, tenderness, itchy skin that feels warm to the touch, and the appearance of inflamed veins.
- Serious allergic reactions. Signs and symptoms of an allergic reaction to COSELA can include hives, itching, flushed or pale skin, trouble breathing, swollen face, eyes, tongue or throat, and dizziness or fainting.
- Lung problems (pneumonitis or interstitial lung disease). Signs or symptoms may include trouble breathing at rest or aggravated by exertion, cough, tiredness, unintended weight loss, loss of appetite, and chest pain. Report any new or worsening problems with breathing to your doctor right away.
- COSELA can harm your unborn baby. Females should use effective birth control during treatment with COSELA. COSELA may cause fertility problems in females, which may affect your ability to have children. Talk to your doctor if you have concerns about fertility.
Call your doctor or get medical care right away if you develop any of these symptoms or conditions.
Before taking COSELA, tell your doctor about all of your health conditions, including if you:
- are taking medication for diabetes, heart disease, or multiple sclerosis
- have liver disease
- are pregnant or plan to become pregnant. COSELA can harm your unborn baby. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with COSELA. Females who are able to become pregnant:
- your doctor should give you a pregnancy test before you start treatment with COSELA
- you should use an effective method of birth control during your treatment for at least 3 weeks after the last dose of COSELA
- are breastfeeding or plan to breastfeed. It is not known if COSELA passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of COSELA.
Tell your doctor about all the medications you are currently taking, including prescription and over-the-counter medicines, vitamins, supplements, and herbal supplements. COSELA and other medicines may affect each other. Keep a list of the medicines you take to show to your healthcare provider or pharmacist when you get a new medicine.
The most common side effects of COSELA include:
- fatigue
- low levels of calcium, potassium, or phosphate in your blood
- high levels of a liver enzyme called aspartate aminotransferase
- headache
- infection in the lungs (pneumonia)
- rash
- reactions related to the infusion
- swelling in the legs or arms
- stomach pain
- blood clots
- a high blood sugar level (hyperglycemia)
These are not all of the possible side effects of COSELA. Call your healthcare provider for medical advice about any side effects you may be experiencing. You are encouraged to report any negative side effects to G1 Therapeutics at 1-800-790-G1TX, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information.
