50 mg/ml powder for oral solution
valganciclovir
What Valcyte is and what it is used for
Valcyte belongs to a group of drugs that act directly to prevent the multiplication of viruses. The active ingredient in the powder, valganciclovir, is converted in the body to ganciclovir. Ganciclovir prevents a virus called cytomegalovirus ( CMV ) from multiplying and attacking healthy cells. In patients with a weakened immune system, CMV can cause infection in the body’s organs. This can be life-threatening.
Valcyte is used for:
- treatment of CMV infection in the retina of the eye in adult patients with acquired immunodeficiency syndrome ( AIDS ). CMV – infection of the retina of the eye can cause vision problems and even blindness.
- to prevent CMV infection in adults and children who are not infected with CMV and who have received an organ transplant from someone who was infected with CMV.
What you need to know before you take Valcyte
Do not take Valcyte:
- if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valcyte:
- if you are allergic to aciclovir, penciclovir, valaciclovir or famciclovir. Other drugs are used in viral infections.
Take special care with Valcyte
- if you have too few white blood cells, red blood cells, or platelets (small cells involved in blood clotting ) in your blood. Your doctor will do blood tests before you start taking Valcyte and more tests will be done while you are using the medicine.
- if you are undergoing radiation therapy.
- if you have kidney problems. Your doctor may need to prescribe you a lower dose and your blood levels may need to be checked frequently during treatment.
Other medicines and Valcyte
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
If you take other medicines at the same time as Valcyte, the combination may affect the amount of medicine absorbed into your blood or possibly cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following:
- imipenem-cilastatin ( antibiotics ). May cause seizures if taken with Valcyte
- zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines used to treat AIDS
- adefovir or other medicines used to treat hepatitis B
- probenecid (medicine for gout ). The amount of ganciclovir in the blood may increase if probenecid and Valcyte are taken at the same time
- mycophenolate mofetil, ciclosporin, or tacrolimus (used after transplantation)
- vincristine, vinblastine, doxorubicin, hydroxyurea, or similar anticancer drugs
- trimethoprim, combinations with trimethoprim/sulfa and dapsone ( antibiotics )
- pentamidine (medicine to treat parasites or lung infections)
- flucytosine or amphotericin B (antifungal
Valcyte with food and drink
Valcyte should be taken with food. If for some reason you cannot eat, you should still take Valcyte as usual.
Pregnancy, breastfeeding, and fertility
You should not take Valcyte if you are pregnant unless your doctor advises you to do so. You must tell your doctor if you are pregnant or planning to become pregnant. Taking Valcyte during pregnancy may harm your unborn baby.
You should not take Valcyte if you are breastfeeding. If your doctor wants to start treatment with Valcyte, you must stop breastfeeding before you start taking the medicine.
Women of childbearing potential must use effective contraception while being treated with Valcyte and for at least 30 days after stopping treatment.
Men whose partners could become pregnant should use condoms while being treated with Valcyte and should continue to use condoms for 90 days after treatment ends.
Driving ability and use of machinery
Do not drive or use tools or machines if you feel dizzy, tired, shaky, or confused while taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Ask your doctor or pharmacist for advice before taking any medicine.
Valcyte contains sodium benzoate and sodium (salt)
This medicine contains 100 mg of sodium benzoate in each 12 g bottle, which corresponds to 1 mg/ml after reconstitution. Benzoate salt may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains a total of 0.188 mg/ml sodium, i.e. it is almost “sodium-free”. This should be taken into account by patients prescribed a low-salt diet.
How to take Valcyte
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
You must handle Valcyte’s solution carefully. You must avoid getting the solution on the skin or in the eyes. If you accidentally get a solution on your skin, wash the area thoroughly with soap and water. If you accidentally get a solution in your eyes, rinse your eyes thoroughly with water.
You must stick to the daily dose of oral solution prescribed by your doctor to avoid overdose.
Valcyte oral solution should, if possible, be taken with food – see section 2.
You must use the dosing syringe included in the package to measure your dose of the Valcyte solution. Do not use the dosing syringe with other products. Two dosing syringes are included in case one of them is lost or damaged. Each dosing syringe is designed to measure up to an amount of 10 ml (500 mg) of solution in 0.5 ml (25 mg) intervals. 1 ml of Valcyte oral solution is equivalent to 50 mg of valganciclovir.
Always clean the dosing syringe thoroughly and let it dry after taking your dose.
Contact a doctor or pharmacist if both dosing syringes are lost or damaged. They will advise how to continue taking your medicine.
Adults:
Prevention of CMV disease in organ transplant patients
You must start taking this medicine within 10 days of the transplant. The usual dose is 900 mg of Valcyte solution taken ONCE daily. Use the dosing syringe provided to take two 9 ml (450 mg) doses (ie 2 syringes filled to the 9 ml (450 mg) graduation) of solution. You should continue this dose until 100 days after the transplant. If you have had a kidney transplant, your doctor may advise you to take one dose for 200 days.
Treatment of active CMV – infection in the retina of the eye in patients with AIDS (so-called induction treatment)
The usual dose is 900 mg of Valcyte solution taken TWICE daily for 21 days (three weeks). Use the dosing syringe provided and take two doses of 9 ml (450 mg) (ie 2 syringes filled to the 9 ml (450 mg) graduation) solution in the morning and two doses of 9 ml (450 mg) (ie two syringes which are filled to the graduation 9 ml (450 mg)) in the evening.
Do not take this dose for more than 21 days unless your doctor tells you to, as your risk of side effects may increase.
Long-term treatment to prevent recurrent active inflammation in AIDS patients with CMV infection in the retina of the eye (so-called maintenance treatment)
The usual dose is 900 mg of Valcyte solution taken ONCE daily. Use the dosing syringe provided and take two doses of 9 ml (450 mg) solution (ie 2 syringes filled to the 9 ml (450 mg) graduation). You should try to take the solution at the same time each day. Your doctor will tell you how long to continue taking Valcyte. If your retinitis worsens while taking this dose, your doctor may ask you to repeat the induction treatment (as above) or decide to give you another medicine to treat CMV infection.
Elderly patients
Valcyte has not been studied in elderly patients.
Patients with kidney problems
If your kidneys are not fully functioning, your doctor may instruct you to take a lower dose of Valcyte solution each day. You must follow the dosage prescribed by your doctor.
Use the dosing syringe that comes with the package to measure out dose one with the Valcyte solution.
Patients with liver problems
Valcyte has not been studied in patients with liver problems.
Use for children and adolescents:
Prevention of CMV disease in organ transplant patients
Children should start taking this medicine within 10 days of the transplant. The dose given varies depending on the size of the child and should be taken ONCE daily. Your doctor will decide on the most appropriate dose based on your child’s height, weight, and kidney function. You should continue with this dose up to 100 days after the transplant. If your child has received a kidney transplant, your doctor may advise you to take the medicine for 200 days.
Use the dosing syringes included in the package to measure out a dose of Valcyte solution.
Method of administration and route of administration
The Valcyte solution is prepared by pharmacists before it is given to you.
Once the solution is ready, follow the instructions below to draw up and take your medication.
- Shake the closed bottle well for about 5 seconds before each use.
- Remove the childproof cover.
- Before the tip of the dosing syringe appears in the bottle adapter, the plunger must be fully pushed in against the tip of the syringe. Push the tip of the dosing syringe firmly into the opening of the bottle adapter.
- Turn everything (bottle and syringe) upside down.
- Slowly pull out the plunger until the desired amount of solution has been drawn up into the dosing syringe (see figure).
- Turn the bottle with the dosing syringe back in an upright position and slowly withdraw the syringe from the bottle.
- Squirt the solution directly into the mouth and swallow. Do not mix with other liquids before spraying in the mouth.
- Close the bottle with the childproof cap after each use.
- Immediately after use: Disassemble the dosing syringe and rinse under running tap water and allow it to air dry before using it again.
Be careful and avoid the solution coming into direct contact with the skin. If it does happen, wash thoroughly with soap and water.
Do not use the solution after the expiry date, which is 49 days after preparation.
If you have taken too much Valcyte
If you have ingested, or think you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. If you have taken more than the recommended dose, you can have serious side effects, especially in the blood and kidneys can be affected. You may need hospital care.
If you forget to take Valcyte
If you forget to take Valcyte, take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Valcyte
Do not stop taking this medicine unless your doctor tells you to.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Up to 1 in 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock ). STOP taking Valcyte and go to the emergency department of your nearest hospital if you experience any of the following:
- increasing itchy skin rash ( hives )
- sudden swelling of the throat, face, lips, and mouth which may cause difficulty swallowing and breathing
- sudden swelling of hands, feet, or ankles
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – your doctor may tell you to stop taking Valcyte and you may need urgent medical treatment:
Very common: may affect more than 1 in 10 patients
- low white blood cell count – with signs of infection such as sore throat, mouth sores, or fever
- low red blood cell count – signs include shortness of breath or tiredness, palpitations, or pale skin
Common: may affect 1 to 10 patients
- blood poisoning ( sepsis ) – signs include fever, chills, palpitations, confusion, and slurred speech
- low platelet count – signs include bleeding or bruising more easily than usual, blood in the urine or stool, or bleeding from the gums. Bleeding can be heavy
- severely low blood levels
- inflammation of the pancreas – signs are severe abdominal pain that spreads to the back
- cramps
Uncommon: may affect 1 to 100 patients
- failure of the bone marrow’s ability to form blood cells
- hallucinations – hearing or seeing things that are not real
- abnormal thoughts or feelings, losing touch with reality
- impaired kidney function
Side effects that occurred during treatment with valganciclovir or ganciclovir are reported below:
Other side effects are
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common: may affect more than 1 in 10 patients
- mushrooms and cod in the mouth
- upper respiratory tract infection (e.g. sinusitis, inflammation of the tonsils)
- loss of appetite
- headache
- cough
- shortness of breath
- diarrhea
- nausea or vomiting
- abdominal pain
- eczema
- fatigue
- fever
Common: may affect up to 1 in 10 patients
- influenza
- urinary tract infection – signs include fever, urinating more often than usual, pain when urinating
- infection in the skin and tissues under the skin
- mild allergic reaction – signs may include red and itchy skin
- weight loss
- feeling depressed, anxious, or confused
- sleep difficulties
- hands or feet feel weak and numb, which can affect balance
- changes in sensation, tingling, tickling, stinging, or burning sensation
- taste changes
- overindulge
- eye inflammation ( conjunctivitis ), pain in the eyes, or vision problems
- earache
- low blood pressure, which can make you feel dizzy or faint
- trouble swallowing
- constipation, flatulence, indigestion, stomach ache, swollen abdomen
- mouth ulcers
- abnormal results on liver and kidney tests
- night sweats
- itching, rash
- hair loss
- back pain, pain in muscles or joints, muscle cramps
- feel dizzy, weak, or generally unwell
Uncommon: may affect up to 1 in 100 patients
- feel upset
- tremors, tremors
- deafness
- irregular heartbeat
- hives, dry skin
- blood in the urine
- infertility in men – see section “Pregnancy, breastfeeding and fertility”
- chest pain
Separation of the inner part of the eye (retinal detachment) has only occurred in AIDS patients treated with Valcyte for CMV infection.
Additional side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults.
How to store Valcyte
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and label after Ex. dat. The expiration date is the last day of the specified month.
Powder: No special storage instructions.
Prepared solution: Store in a refrigerator (2°C-8°C).
The shelf life of the oral solution is 49 days. Use the solution within 49 days after it is made (the pharmacy staff writes the date of preparation on the bottle).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is valganciclovir hydrochloride. After the dissolution of the powder, 1 ml of solution contains 55 mg of valganciclovir hydrochloride equivalent to 50 mg of valganciclovir (as hydrochloride).
Other ingredients (excipients) are Povidone, fumaric acid, sodium benzoate (E211), saccharin sodium and mannitol, tutti-frutti flavoring [maltodextrins (corn), propylene glycol, acacia gum E414 and nature-identical flavorings mainly consisting of banana, pineapple, and peach flavors].
Appearance and package sizes of the medicine
The valcyte powder is a granule with a white to light yellow color. The glass bottle contains 12 g of powder. After preparation, the amount of solution is 100 ml, which gives a usable volume of 88 ml. The solution is clear and colorless to brown. The package also contains a bottle adapter and 2 dosing syringes graduated up to 10 ml (500 mg) with graduations in 0.5 ml (25 mg) intervals.
Package size: One bottle containing 12 g of powder.
Marketing Authorisation Holder
Roche AB, Box 1228, 171 23 Solna
Manufacturer
Roche Pharma AG
Emil-Barrell-Str. 1
79639 Grenzach-Wyhlen
Germany
Phone: (07624) 14-0
Fax: (07624) 10 19
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Lindigstrasse 6
63801 Kleinostheim
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany
This medicine is approved in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
Valcyte: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lichtenstein, Lithuania, Luxembourg, Netherlands, Norway, Poland, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland)
Valcyte: France, Portugal