Cidofovir Solution for injection

What is this medicine?

CIDOFOVIR (si DOF o veer) is an antiviral medicine. It is used to treat or prevent infections caused by certain kinds of viruses. It is commonly used to treat cytomegalovirus (CMV) infections of the eye.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• chronic diarrhea

• dehydration

• diabetes

• kidney disease

• low levels of white cells in the blood

• previous treatment with foscarnet

• an unusual or allergic reaction to cidofovir, probenecid, other medicines, foods, dyes, or preservatives

• pregnancy or recent attempts to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

You will need to take another medicine, probenecid, with this medicine. Take all of your medicine as directed. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• medicines for infection like acyclovir, adefovir, amphoterin B, bacitracin, cidofovir, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• tacrolimus

This medicine may also interact with the following medications:

• aspirin and aspirin-like medicines

• cisplatin

• cyclosporine

• pamidronate

• zidovudine

• zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need regular blood checks. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

This medicine is used to treat cytomegalovirus (CMV) infections of the eye(s). This medicine is not a cure for CMV. Life long therapy may be needed.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Women: use effective birth control methods during treatment with this medicine and for 1 month after stopping therapy. Men: use barrier contraceptive methods during treatment with this medicine and for 3 months after stopping therapy.

This medicine has caused breast cancer in animal studies. Talk to your doctor about the risks and benefits of taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in hearing, 'ringing' in the ears

• changes in vision

• fast, irregular heartbeat

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• swelling of the ankles, hands, feet

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches, pains

• dry skin

• loss of hair

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.