Generic Name: Valganciclovir Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Valganciclovir used for?

Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body.

Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness.

Valganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

How should I take Valganciclovir?

Take this medication by mouth with food, usually 1 to 2 times a day or as directed by your doctor. Swallow the tablets whole. Do not crush or break the tablets.

If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using the special measuring device provided. Do not use a household spoon because you may not get the correct dose.

Wash your hands well after handling this drug. Avoid contact with broken/crushed tablets and the liquid form of this medication on your skin, in your mucous membranes and eyes, and avoid breathing in the dust from the tablets. If contact should occur, wash the area thoroughly with soap and water. If this medication gets in your eyes, rinse them thoroughly with plain water.

The dosage and length of treatment is based on your medical condition (especially kidney function). In children, the dosage is also based on their body size. The doctor should keep track of your child’s height and weight to make sure that the dose is right for them.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

Continue taking this medication exactly as prescribed by your doctor. Do not change your dose or stop taking it even for a short time unless directed to do so by your doctor. Changing or skipping your dose without approval from your doctor may increase the risk of side effects or make the infection worse.

Do not take ganciclovir instead of valganciclovir on your own without consulting your doctor or pharmacist. The effects and the dosages of ganciclovir and valganciclovir are not equal.

Keep all medical and laboratory appointments.

Tell your doctor if your condition worsens (such as worsening vision).

How do I store Valganciclovir?

Store valganciclovir tablets at room temperature away from moisture and heat.

Store valganciclovir liquid in the refrigerator. Do not freeze. Throw away any unused after 49 days.

There may be different brands of Valganciclovir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Valganciclovir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Valganciclovir?

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. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

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.

Older adults may be at greater risk for kidney problems while using this drug.

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. Women of child-bearing age should have a pregnancy test before starting this medication. 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 reliable forms of birth control (such as birth control pills and condoms) during treatment and for at least 30 days after stopping the medication. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Valganciclovir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Valganciclovir. Valganciclovir is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Valganciclovir?

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 right away if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), signs of kidney problems (such as 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Valganciclovir?

Some products that may interact with this drug include: didanosine, imipenem/cilastatin.

You may be taking other drugs that decrease bone marrow function and lower your number of blood cells (such as cancer chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other drugs that may cause kidney problems (such as cyclosporine). Your doctor or pharmacist will monitor you closely and adjust your medications to decrease your risk of serious side effects.

Valganciclovir is very similar to ganciclovir. Do not use medications containing ganciclovir while using valganciclovir.

Valganciclovir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Valganciclovir?

Valganciclovir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Valganciclovir?

Valganciclovir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

 

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Valganciclovir.

What is the dose of Valganciclovir for an adult?

Usual Adult Dose for CMV Retinitis

Induction dose: 900 mg orally twice a day for 21 days

Maintenance dose: 900 mg orally once a day

Comments:

-The tablet formulation should be used, not the oral solution.

-The maintenance dose should be used after the induction dose or in patients with inactive CMV retinitis.

Use: For the treatment of CMV retinitis in patients with AIDS

Usual Adult Dose for CMV Prophylaxis

900 mg orally once a day

Duration of therapy:

-Heart or kidney-pancreas transplant patients: Until 100 days posttransplantation.

-Kidney transplant patients: Until 200 days posttransplantation.

Comments:

-The tablet formulation should be used, not the oral solution.

-Therapy should be started within 10 days of transplantation.

Use: For the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)

Renal Dose Adjustments

Adults and adolescents older than 16 years:

CrCl 40 to 59 mL/min:

-Induction dose: 450 mg orally twice a day

-Maintenance/prevention dose: 450 mg orally once a day

CrCl 25 to 39 mL/min:

-Induction dose: 450 mg orally once a day

-Maintenance/prevention dose: 450 mg orally every 2 days

CrCl 10 to 24 mL/min:

-Induction dose: 450 mg orally every 2 days

-Maintenance/prevention dose: 450 mg orally twice a week

Pediatrics: Dosing in pediatric patients with renal dysfunction can be done using the recommended equations as CrCl is a component in the calculation.

Comments: Serum creatinine levels or CrCl should be monitored regularly during therapy; dose should be adjusted as appropriate.

Dialysis

Adults and adolescents older than 16 years:

Hemodialysis (CrCl less than 10 mL/min): Not recommended.

Comments: A reduced dose of ganciclovir is recommended; the manufacturer product information for ganciclovir should be consulted.

Other Comments

Administration advice:

-Administer with food.

-Use the tablet formulation in adults and adolescents older than 16 years, not the oral solution.

-Do not break or crush tablets.

-Use caution when handling this drug (tablets or oral solution).

What is the dose of Valganciclovir for a child?

Usual Pediatric Dose for CMV Prophylaxis

1 month to 16 years (heart transplant recipients) or 4 months to 16 years (kidney transplant recipients):

The recommended once-daily oral dose is based on BSA and CrCl derived from a modified Schwartz formula, and is calculated using the following equation:

Pediatric dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula)

-If the calculated Schwartz CrCl exceeds 150 mL/min/1.73 m2, then a maximum value of 150 mL/min/1.73 m2 should be used in the equation.

Mosteller BSA (m2) = the square root of (height [cm] x weight [kg] divided by 3600)

Schwartz CrCl (mL/min/1.73 m2) = k x height (cm) divided by serum creatinine (mg/dL)

k values:

-Infants less than 1 year of age with low birth weight for gestational age: 0.33

-Infants less than 1 year of age with birth weight appropriate for gestational age: 0.45

-Children aged 1 to less than 2 years: 0.45

-Boys aged 2 to less than 13 years and girls aged 2 to less than 16 years: 0.55

-Boys aged 13 to 16 years: 0.7

Maximum dose: 900 mg orally once a day

Older than 16 years: 900 mg orally once a day

Duration of therapy:

-Heart transplant patients (1 month or older): Until 100 days posttransplantation.

-Kidney transplant patients (4 months or older): Until 200 days posttransplantation.

-Kidney-pancreas transplant patients (older than 16 years): Until 100 days posttransplantation.

Comments:

-The recommended once-daily dose should be started within 10 days of transplantation.

-The k values provided are based on the Jaffe method of measuring serum creatinine; correction may be necessary when enzymatic methods are used.

-During prophylaxis, the calculated dose should be adjusted as appropriate; serum creatinine levels should be monitored regularly and changes in height and body weight should be considered.

-All calculated doses should be rounded to the nearest 10 mg increment for actual deliverable dose, up to maximum dose of 900 mg.

-The oral solution is the preferred formulation for patients 1 month to 16 years; it provides the ability to administer a dose calculated according to the formula above. The tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg); for example, one 450 mg tablet may be used for calculated doses between 405 mg and 495 mg.

-The oral solution should be used for patients 1 month to 16 years unable to reliably swallow a tablet.

-Patients older than 16 years should use the tablet formulation, not the oral solution.

Uses: For the prevention of CMV disease:

-In heart transplant recipients (1 month or older) at high risk

-In kidney transplant recipients (4 months or older) at high risk

-In kidney-pancreas transplant recipients (older than 16 years) at high risk

Usual Pediatric Dose for CMV Retinitis

Older than 16 years:

Induction dose: 900 mg orally twice a day for 21 days

Maintenance dose: 900 mg orally once a day

Comments:

-The tablet formulation should be used, not the oral solution.

-The maintenance dose should be used after the induction dose or in patients with inactive CMV retinitis.

Use: For the treatment of CMV retinitis in patients with AIDS

Precautions

Safety and efficacy have not been established for children (up to 16 years) for prevention of CMV disease in pediatric liver transplant patients, in heart transplant patients younger than 1 month, in kidney transplant patients younger than 4 months, in pediatric AIDS patients with CMV retinitis, or in infants with congenital CMV infection.

How is Valganciclovir available?

Valganciclovir is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral powder for reconstitution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Valganciclovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: July 27, 2018 | Last Modified: July 27, 2018

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