Important Safety Information
Important Safety Information
Gleostine® (lomustine) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of Gleostine® (see WARNINGS and ADVERSE REACTIONS).
Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of Gleostine® should not be given more frequently than every 6 weeks.
The bone marrow toxicity of Gleostine® is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see dosage adjustment table under DOSAGE AND ADMINISTRATION)
Everyone reacts differently to Gleostine® therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of side effects.
Gleostine® can cause fetal harm when administered to a pregnant woman.
- If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus.
- Women of childbearing potential should be advised to avoid becoming pregnant.
Hematologic Toxicity [Low white blood cells (leukopenia) and low platelets (thrombocytopenia)]
Gleostine® may cause low white blood cells and low platelets. Your doctor may prescribe blood transfusion or certain medicines if your blood counts drop too low. Your blood counts may be checked weekly between doses of Gleostine®.
Contact your physician, nurse or healthcare provider immediately if you experience any of the following symptoms:
- Unusual Bleeding
- Excessive Bruising
- Fever, Chills, Sore Throat
- Tired, Weak, Fatigue
Consult with your physician, nurse or healthcare practitioner about any side effects or new symptoms you experience during your treatment.
Gleostine® can affect your lung functions. Your doctor may order some initial, as well as periodic, lung function tests. Contact your doctor or nurse if you experience any of the following symptoms:
- Shortness of Breath
- Swelling of Feet or Lower Legs
- Dry Cough
- Yellowing of Eyes and Skin
- Mental Confusion
Nausea and vomiting may occur 3 to 6 hours after taking Gleostine® and usually last less than 24 hours. Your doctor may prescribe medications that are e ective in diminishing and sometimes preventing this side e ect. Nausea and vomiting can also be reduced if Gleostine® is taken while fasting.
Increases in certain laboratory tests can mean your liver is being a ected by taking Gleostine®. If this happens, your healthcare provider may stop treatment with Gleostine® until laboratory test return to normal.
Increases in certain laboratory tests can mean your kidneys are being a ected by taking Gleostine®. If this happens, your healthcare provider may stop treatment with Gleostine® until laboratory test return to normal.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING GLEOSTINE®?
If you are pregnant or plan on becoming pregnant, Gleostine® has the potential to cause birth defects if taken during pregnancy. Do not take Gleostine® if you plan on becoming pregnant or you are currently pregnant. Your doctor will discuss your options for taking Gleostine®.
Make sure to discuss with your healthcare practitioner any other medicines you are taking, including non-prescription and prescription drugs as well as vitamins and herbal supplements. It is important to let your doctor or nurse know which medications you are taking. There is always a possibility that Gleostine® and other medicines may affect each other, causing serious side effects.
Medications can cause you adverse effects while taking Gleostine®. Make sure to discuss with your healthcare practitioner any other medicines you are taking including non- prescription and prescription drugs as well as vitamins and herbal supplements.
WHAT SHOULD I ASK MY DOCTOR BEFORE TAKING GLEOSTINE®?
Decisions regarding your treatment choices are very important. In order to make the right decision, you and your doctor need to have all the facts. The following are some questions you may want to ask your doctor:
- Why are you choosing Gleostine® to treat my brain cancer?
- How long will I be taking Gleostine®?
- How will taking Gleostine® affect my ability to function?
- How will I feel during treatment with Gleostine®?
- What side effects are common with Gleostine®?
- Who should I contact when side effects occur?
Other side effects may occur when taking Gleostine®. Make sure to always consult with your physician, nurse or healthcare provider about any side effects that bother you or do not go away.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You can also reach Medical Affairs at 855-672-2468, Option 3.
Please see full Product Information, including Serious Side Effects, for additional important safety information.