Gliadel (injection/implant)

Gliadel is used in adults by itself or along with other cancer treatments to treat brain tumors, Hodgkin's disease, multiple myeloma, and non-Hodgkin's lymphoma.

Gliadel may also be used for reasons not mentioned in this medication guide.

You may experience infections or increased bleeding, which can include serious or fatal infections. Contact your doctor if you have shortness of breath when exerting yourself, chest discomfort, a dry cough or a hacking cough, feelings of weakness or fatigue, rapid weight loss, unusual bleeding, fever, painful urination, night sweats, neck stiffness, confusion, or vision issues.

Gliadel can lead to serious or fatal lung problems, even months or years after you have used this medicine.

You should not be treated with Gliadel if you are allergic to it.

Tell your doctor if you have or have ever had:

• lung disease or breathing problems;
• bone marrow suppression; or
• kidney disease.

Receiving Gliadel injection may increase your risk of developing other cancers. Ask your doctor about this risk.

Gliadel can harm an unborn baby if the mother or the father is using Gliadel.

• If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while receiving Gliadel, or for at least 7 days after this medicine implant placement.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregivers if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Gliadel can cause serious or fatal lung problems, even months or years after you have used Gliadel.

You may also bleed or get infections more easily, including serious or fatal infections. Call your doctor right away if you have:

• shortness of breath when you exert yourself;
• chest discomfort, dry cough or hacking;
• mouth sores, red or swollen gums;
• feeling weak or tired, loss of appetite, rapid weight loss;
• unusual bleeding, pale skin, easy bruising;
• fever, chills, sore throat, night sweats; or
• confusion, vision problems.

Also call your doctor immediately if you have:

• a seizure;
• little or no urination;
• abnormal liver function tests;
• pain, bruising, swelling, or irritation where the medicine was injected;
• slow healing of your incision after Gliadel implant placement;
• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of meningitis--fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness.

Common side effects of Gliadel may include:

• feeling weak or tired;
• abnormal wound healing;
• kidney problems;
• constipation, fever;
• urinary tract infections;
• depression, swelling in your head;
• low blood cell counts;
• nausea, vomiting; or
• breathing problems.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gliadel injection is given as an infusion into a vein, usually once every 6 weeks. A healthcare provider will give you this injection.

You may be given other medications to help prevent serious side effects.

Tell your medical caregivers if you feel any burning or pain when Gliadel is injected.

Gliadel implant is placed in your brain after brain tumor removal surgery.

Gliadel can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

Your blood will also need to be tested weekly, for at least 6 weeks and your dose may be changed based on the results.

You may also need chest X rays or breathing tests.

Call your doctor for instructions if you miss an appointment for your Gliadel (injection/implant).

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's guidance regarding any limits on food, drinks, or activities.

Tell your doctor about all the other medicines you are taking, especially:

• seizure medicine like phenobarbital; or
• cimetidine.

This list is not complete. Other drugs may affect Gliadel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.