Gemcitabine Hydrochloride, Injection

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KEY POINTS

• This medicine is given by IV to treat several types of cancer.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: gemcitabine hydrochloride, injection; Gemzar

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat cancer of the pancreas.

This medicine, along with another anticancer drug, may also be used to treat non-small cell lung cancer, ovarian cancer, or breast cancer.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart problems
• Lung disease
• Kidney or liver disease

Also tell your healthcare provider if you have recently had radiation treatments.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine.

How do I use it?

This is a very strong medicine. Only healthcare providers experienced with this drug should prescribe it. It should only be given in a clinic or hospital where you can be monitored closely. Infusions are given by your healthcare provider. Keep all your appointments for this treatment.

These infusions are usually given once a week for about 7 weeks. Additional treatments may be needed.

What should I watch out for?

You need frequent urine tests and blood tests to avoid certain severe side effects. Keep all your appointments for these tests.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make your mouth sore. Use a soft bristle brush or mouth swab to brush your teeth.

This medicine may cause nausea and vomiting. Your healthcare provider may give you medicine to help. Contact your provider you continue to feel sick and throw up.

This medicine may cause posterior reversible encephalopathy syndrome. If you have vision changes, seizures, confusion, or a severe headache, contact your healthcare provider right away.

This medicine may cause you to bleed more easily. Talk with your healthcare provider before taking aspirin or other medicines.

If you need emergency care, surgery, lab tests, or dental work, tell all healthcare providers or dentists that you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe nausea or vomiting; fever; unexplained sore throat; unusual bruising or bleeding; stomach pain; black or tarry bowel movements; bleeding gums; nosebleeds; blood in urine; dark urine; decreased urination; yellowing of your skin or eyes; confusion; swelling of hands or ankles or any unexplained swelling; unusual tiredness or lightheadedness; numbness or tingling in fingers or toes; muscle aches and pains; severe headache; shortness of breath or wheezing; seizures; vision problems.

Other: Depression, mild tiredness, hair loss, drowsiness, mouth sores, mild diarrhea, constipation, redness or swelling at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amphotericin b (Abelcet, AmBisome, Amphotec)
• Antibiotics such as amikacin, gentamicin, tobramycin, and vancomycin (Vancocin)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) and phenytoin (Dilantin, Phenytek)
• Arthritis medicines such as leflunomide (Arava) and tofacitinib (Xeljanz)
• Aspirin and other salicylates
• Clozapine (Clozaril, FazaClo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Live vaccines
• Medicines to raise white blood cell counts such as filgrastim (Neupogen), pegfilgrastim (Neulasta), and sargramostim (Leukine)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other cancer medicines

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.