Valcyte

DRUG DESCRIPTION

Valcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.

Valcyte (valganciclovir hcl) is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®.

Valcyte (valganciclovir hcl) is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of Valcyte (valganciclovir hcl) for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring.

Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5·HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6.

The chemical structure of valganciclovir HCl is:

Valcyte (valganciclovir hydrochloride) Structural Formula Illustration

All doses in this insert are specified in terms of valganciclovir.

What are the possible side effects of valganciclovir (Valcyte)?

Stop taking valganciclovir and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • easy bruising, unusual bleeding;
  • numbness or tingling in a part of the body;
  • signs of infection (fever, chills, body aches, flu symptoms); or
  • seizure (convulsions).

Other, less serious side...

Read All Potential Side Effects and See Pictures of Valcyte »

What are the precautions when taking valganciclovir hcl (Valcyte)?

Before taking valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of...

Read All Potential Precautions of Valcyte »


Valcyte Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, or shaking (tremors) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug.

Based on animal studies, this medication may reduce fertility in men and women.

Women who are pregnant or who may become pregnant should not handle this medication.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. To prevent pregnancy, men with female partners should always use effective barrier protection (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age who are taking valganciclovir should use at least 2 reliable forms of birth control (such as birth control pills and condoms). Consult your doctor for more details.

It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.


Valcyte Patient Information Including Side Effects

Brand Names: Valcyte

Generic Name: valganciclovir (Pronunciation: val gan SYE kloe veer)

  • What is valganciclovir (Valcyte)?
  • What are the possible side effects of valganciclovir (Valcyte)?
  • What is the most important information I should know about valganciclovir (Valcyte)?
  • What should I discuss with my healthcare provider before taking valganciclovir (Valcyte)?
  • How should I take valganciclovir (Valcyte)?
  • What happens if I miss a dose (Valcyte)?
  • What happens if I overdose (Valcyte)?
  • What should I avoid while taking valganciclovir (Valcyte)?
  • What other drugs will affect valganciclovir (Valcyte)?
  • Where can I get more information?/

What is valganciclovir (Valcyte)?

Valganciclovir is an antiviral drug. It works by preventing viral cells from multiplying in your body. Valganciclovir will not cure CMV but it can help control the infection.

Valganciclovir treats cytomegalovirus (CMV) infection of the eye in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir also prevents CMV infection in patients who have received an organ transplant (kidney, heart, or kidney-pancreas).

Valganciclovir may also be used for purposes other than those listed in this medication guide.

Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). Be aware that the strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed. An overdose of this medication can cause serious illness.

What are the possible side effects of valganciclovir (Valcyte)?

Stop taking valganciclovir and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • easy bruising, unusual bleeding;
  • numbness or tingling in a part of the body;
  • signs of infection (fever, chills, body aches, flu symptoms); or
  • seizure (convulsions).

Other, less serious side effects may be more likely to occur. Continue to take valganciclovir and talk to your doctor if you experience:

  • mild nausea, vomiting, diarrhea, stomach pain;
  • headache;
  • sleepiness or dizziness;
  • weakness, lack of coordination;
  • confusion;
  • tremor (uncontrolled shaking); or
  • sleep problems (insomnia).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about valganciclovir (Valcyte)?

Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together. If your doctor switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte), the number of pills you use each day may change. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed.

Using valganciclovir while you are pregnant may cause harm to the unborn baby. If a man fathers a child while using this medication, the baby may have birth defects. Use an effective form of birth control while you are using valganciclovir. If you are a man, use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir.

Do not use a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If you must handle a broken tablet, ask your doctor or pharmacist how to handle and dispose of the tablet safely.

Valganciclovir can lower the blood cells in your body that control bleeding and help you fight infection. Your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. Contact your doctor right away if you have any bleeding or signs of infection (fever, chills, body aches, or flu symptoms).

Related Drug Centers
  • Valcyte


Related Drugs Index: