200 mg powder for infusion solution
voriconazole
What Voriconazole Fresenius Kabi is and what it is used for
Voriconazole Fresenius Kabi contains the active substance voriconazole. Voriconazole Fresenius Kabi is a medicine against fungal infections. It works by killing or stopping the growth of the fungi that cause the infection.
It is used to treat patients (adults and children from 2 years of age) with:
- invasive aspergillosis (a type of fungal infection caused by Aspergillus sp )
- candidemia (another type of fungal infection caused by Candida sp ) in non-neutropenic patients (patients without abnormally low white blood cell counts )
- severe invasive Candida sp. infection when the fungus is resistant to fluconazole (another antifungal medicine)
- severe fungal infections caused by Scedosporium sp. or Fusarium sp . (two different mushroom species).
Voriconazole Fresenius Kabi is intended for patients with worsening and possibly life-threatening fungal infections.
Preventive treatment in stem cell transplant patients who are at high risk of developing a fungal infection.
This product should only be used under medical supervision.
The voriconazole contained in Voriconazole Fresenius Kabi may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Voriconazole Fresenius Kabi
Do not use Voriconazole Fresenius Kabi
- if you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
You must tell your doctor or pharmacist if you are taking or have taken any other medicines, including over-the-counter medicines or (traditional) herbal and herbal medicines.
The following medicines must not be taken during your treatment with Voriconazole Fresenius Kabi:
- terfenadine (used for allergies)
- astemizole (used for allergy )
- cisapride (used for stomach upset)
- pimozide (used to treat mental illness)
- quinidine (used for irregular heartbeat)
- ivabradine (used for symptoms of chronic heart failure )
- rifampicin (used in the treatment of tuberculosis )
- efavirenz (used to treat HIV ) at doses of 400 mg or more once daily
- carbamazepine (used to treat seizures)
- phenobarbital (used for severe sleep disorders and convulsions)
- ergot alkaloids (eg, ergotamine, dihydroergotamine; used for migraine )
- sirolimus (used in transplant patients)
- ritonavir (used in the treatment of HIV ) at a dose of 400 mg or more twice daily
- St. John’s wort ((traditional) herbal medicine)
- naloxegol (used to treat constipation specifically caused by painkillers called opioids (eg morphine, oxycodone, fentanyl, tramadol, codeine ))
- tolvaptan (used to treat hyponatremia (low levels of sodium in the blood) or to slow the deterioration of kidney function in patients with polycystic kidney disease)
- lurasidone (used to treat depression)
- venetoclax (used in the treatment of patients with chronic lymphocytic leukemia – CLL )
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Voriconazole Fresenius Kabi if:
- you have previously had an allergic reaction to other azoles
- you have or have previously had liver disease. If you have liver disease, the doctor may prescribe a lower dose of Voriconazole Fresenius Kabi. The doctor must also check your liver function through blood tests during the time you are treated with Voriconazole Fresenius Kabi
- you have a known disease of the heart muscle, irregular heartbeats, slow heartbeats, or an ECG change called “long QTc syndrome”.
Avoid all sunlight and exposure to the sun while you are being treated. It is important to cover exposed areas of the skin and to use sunscreen with a high sun protection factor (SPF), as the skin can become more sensitive to the sun’s UV rays. These precautions also apply to children.
While you are being treated with Voriconazole Fresenius Kabi:
- tell your doctor immediately if you receive
- sun damage
- skin rash or blisters
- bone pain
If you develop the above skin problems, your doctor may refer you to a dermatologist who, after a consultation, may decide that it is important for you to be examined regularly. There is a small risk of developing skin cancer during long-term use of Voriconazole Fresenius Kabi.
Tell your doctor if you develop signs of ‘adrenal insufficiency. This means that the adrenal glands do not produce enough of certain steroid hormones such as cortisol, which can lead to symptoms such as chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, and abdominal pain.
Talk to your doctor if you develop signs of Cushing’s syndrome. This means that the body produces too much of the hormone cortisol, which can lead to symptoms such as weight gain, lumps of fat between the shoulder blades, a round face, darker skin on the stomach, thighs, breasts, and arms, thin skin, bruising more easily, high blood sugar, excessive hair growth, excessive sweating.
Your doctor checks liver and kidney function by taking certain blood samples.
Children and young people
Voriconazole Fresenius Kabi should not be given to children under 2 years of age.
Other medicines and Voriconazole Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Some medicines can affect or be affected by the simultaneous use of Voriconazole Fresenius Kabi.
Tell your doctor if you are taking any of the following medicines, as Voriconazole Fresenius Kabi should not be taken at the same time if it can be avoided:
- ritonavir (for the treatment of HIV ) in a dose of 100 mg twice daily
- glasdegib (for cancer treatment) – if you need to be treated with both medicines, your doctor will check your heart rhythm frequently.
Tell your doctor if you are taking any of the following medicines, as concomitant treatment with Voriconazole Fresenius Kabi should be avoided if possible, and dose adjustment of voriconazole may be necessary:
- rifabutin (for the treatment of tuberculosis ). If you are already being treated with rifabutin, your blood values and side effects must be monitored.
- phenytoin (for the treatment of epilepsy ). If you are already being treated with phenytoin, the concentration of phenytoin in the blood must be monitored during treatment with Voriconazole Fresenius Kabi and the dose may need to be adjusted.
Tell your doctor if you are taking any of the following medicines as a dose adjustment or control may need to be done to ensure that these medicines and/or Voriconazole Fresenius Kabi still have the desired effect:
- warfarin and other anticoagulants (eg phenprocoumon, acenocoumarol; used to inhibit the blood’s ability to clot)
- ciclosporin (used in transplant patients)
- tacrolimus (used in transplant patients)
- sulfonylureas (eg tolbutamide, glipizide and glyburide) (used for diabetes )
- statins (eg atorvastatin, simvastatin ) (cholesterol-lowering drugs)
- benzodiazepines (eg midazolam, triazolam) (used for severe sleep disorders and stress)
- omeprazole (used in the treatment of stomach ulcers )
- Birth control pills (if you take Voriconazole Fresenius Kabi at the same time as birth control pills, you may experience side effects such as nausea and menstrual disturbances)
- vinca alkaloids (eg vincristine and vinblastine) (used in the treatment of cancer)
- tyrosine kinase inhibitors (eg axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer)
- tretinoin (used in the treatment of leukemia )
- indinavir and other HIV protease inhibitors (used in the treatment of HIV )
- non-nucleoside reverse transcriptase inhibitors (eg efavirenz, delavirdine, nevirapine) (used to treat HIV ) (some doses of efavirenz must NOT be used at the same time as Voriconazole Fresenius Kabi
- methadone (used to treat heroin addiction)
- alfentanil and fentanyl and other short-acting opiates such as sufentanil (painkillers used in surgery)
- oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
- non-steroidal anti-inflammatory drugs (eg ibuprofen, diclofenac ) (used to treat pain and inflammation )
- fluconazole (used for fungal infections)
- everolimus (used in the treatment of advanced kidney cancer and transplant patients).
- letermovir (used to prevent cytomegalovirus ( CMV ) disease after bone marrow transplantation)
- ivacaftor (used in the treatment of cystic fibrosis ).
- corticosteroids such as prednisolone (used in the treatment of various diseases involving inflammation in the body), inhaled corticosteroids such as budesonide (used to reduce and prevent swelling and inflammation in your lungs) and intranasal corticosteroids (used in the treatment of allergies, nasal congestion or swelling of the nose)
Pregnancy and breastfeeding
Voriconazole Fresenius Kabi must not be taken during pregnancy unless prescribed by your doctor. Effective contraception must be used by women of childbearing age. Contact your doctor immediately if you become pregnant while being treated with Voriconazole Fresenius Kabi.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Voriconazole may cause blurred vision or unpleasant sensitivity to light. While you are experiencing something like this, do not drive, or use tools or machines. Contact your doctor if you experience this.
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.
Voriconazole Fresenius Kabi contains sodium
This medicine contains up to 69 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 3.45% of the maximum recommended daily intake for adults.
Voriconazole Fresenius Kabi contains a cyclodextrin
This medicine contains 2660 mg of cyclodextrin per vial. If you have kidney disease, talk to your doctor before receiving this medicine.
How to use Voriconazole Fresenius Kabi
Always take this medicine as directed by your doctor. Consult your doctor if you are unsure.
Your doctor will decide your dose depending on your weight and the type of infection you have.
Your doctor may change the dose depending on your condition.
| Intravenously | |
| Dose for the first 24 hours( Charging dose ) | 6 mg/kg every 12 hours for the first 24 hours |
| Dose after the first 24 hours (Maintenance dose) | 4 mg/kg twice daily |
Depending on how the treatment works, the doctor may lower the dose by one to 3 mg/kg twice daily.
The doctor may prescribe a reduction in dose if you have mild to moderate liver dysfunction.
Use for children and adolescents
| Intravenously | ||
| Children from 2 years up to 12 years and young people 12 – 14 years weighing less than 50 kg | Young people 12 – 14 years who weigh more than 50 kg, as well as young people older than 14 years | |
| Dose for the first 24 hours( Charging dose ) | 9 mg/kg every 12 hours for the first 24 hours | 6 mg/kg every 12 hours for the first 24 hours |
| Dose after the first 24 hours (Maintenance dose) | 8 mg/kg twice daily | 4 mg/kg twice daily |
Depending on how the treatment works, the doctor may increase or decrease the daily dose.
Voriconazole Fresenius Kabi will be mixed and diluted to the correct concentration by the hospital pharmacist or nurse (See the end of this leaflet for further information).
It will be given to you as an intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour over 1-3 hours.
If you or your child are receiving Voriconazole Fresenius Kabi to prevent fungal infections, the doctor may stop giving Voriconazole Fresenius Kabi if you or your child develop side effects caused by the treatment.
If you forget to use Voriconazole Fresenius Kabi
As this medicine is given under medical supervision, it is unlikely that a dose would be missed. If you still think that a dose has been forgotten, tell your doctor, pharmacist, or nurse.
If you stop using Voriconazole Fresenius Kabi
Treatment with Voriconazole Fresenius Kabi will last as long as the doctor decides, however, the duration of treatment with Voriconazole Fresenius Kabi should not exceed 6 months.
Patients with a weakened immune system or with severe infections may need long-term treatment to prevent the infection from recurring. When your condition improves, you may be able to switch from intravenous treatment to tablets.
When the doctor decides to stop treatment with Voriconazole Fresenius Kabi, you should not notice any effects.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any side effects occur, most are likely to be minor or temporary. However, some can be serious and require medical attention.
Serious side effects – Stop taking Voriconazole Fresenius Kabi and see a doctor immediately
- Rash
- Jaundice; changes in blood tests that test liver function
- Inflammation of the pancreas (symptoms may include: abdominal pain, nausea, vomiting)
Other side effects are
Very common (may affect more than 1 in 10 people):
- Visual impairment (vision changes including blurred vision, altered color vision, abnormal hypersensitivity to light, color blindness, eye disorders, the experience of halo phenomenon, night blindness, oscillating visual experience, flashes in the visual field et, visual aura, decreased visual acuity, enhanced visual perception of light, loss of parts of the normal visual field et, spots before the eyes (fly vision)
- Fever
- Rash
- Nausea, vomiting, diarrhea
- Headache
- Swollen arms and legs
- Stomach pains
- Difficulty breathing
- Elevated liver enzyme levels
Common (may affect up to 1 in 10 people):
- Sinusitis, inflammation of the gums, chills, weakness
- Low count, even severe, of certain types of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low count of thrombocytes ( platelets ) – cells that help blood clot
- Low blood sugar, low level of potassium in the blood, low level of sodium in the blood
- Anxiety, depression, confusion, agitation, difficulty sleeping, hallucinations
- Cramps, tremors or uncontrolled muscle movements, tingling or abnormal sensation in the skin, increased muscle tension, sleepiness, dizziness
- Bleeding in the eye
- Heart rhythm problems include a very fast heartbeat, prolonged heart rate, fainting
- Low blood pressure, inflammation of a blood vessel (which may be associated with blood clot formation)
- Acute breathing difficulties, chest pain, swelling of the face (mouth, lips, and around the eyes), fluid accumulation in the lungs
- Constipation, indigestion, inflammation of the lips
- Jaundice, liver inflammation, and liver damage
- Skin rash that can lead to severe blistering and peeling of the skin characterized by a flat, red area of skin covered with small contiguous bumps, redness of the skin
- Itching
- Hair loss
- Back pain
- Kidney failure, blood in the urine, altered kidney function values
Uncommon (may affect up to 1 in 100 people):
- Flu-like symptoms, irritation, and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic-associated diarrhea, inflammation of the lymphatic vessels
- Inflammation of the thin tissue along the inner abdominal wall that covers the organs in the abdomen
- Enlarged lymph nodes (sometimes painful), bone marrow failure, more eosinophils
- Impaired function of the adrenal gland, underactive thyroid gland
- Abnormal brain function, Parkinson-like symptoms, nerve damage resulting in numbness, pain, tingling, or burning in the hands or feet
- Problems with balance or coordination
- Swelling in the brain
- Double vision, serious eye conditions including pain and inflammation of the eyes and eyelids, abnormal eye movements, damage to the optic nerve leading to vision loss, swelling of the blind spot
- Decreased sensitivity to touch
- Abnormal sense of taste
- Hearing problems, ringing in the ears, vertigo
- Inflammation of certain internal organs, the pancreas, and duodenum, swelling and inflammation of the tongue
- Enlarged liver, liver failure, gall bladder diseases, gallstones
- Arthritis, is inflammation of the veins under the skin (which may be associated with the formation of a blood clot)
- Inflammation in the kidneys, protein in the urine, kidney damage
- Very fast heart rate or skipped heartbeats, sometimes with irregular electrical impulses
- Abnormal electrocardiogram ( ECG )
- An elevated level of cholesterol in the blood. increased level of urea in the blood
- Allergic skin reactions (sometimes serious), including life-threatening skin diseases that cause painful blisters and sores on the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn, or severe skin reaction after exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which can be caused by a low number of blood platelets, eczema
- Infusion site reaction
- Allergic reactions or excessive immune response
Rare (may affect up to 1 in 1,000 people):
- Overactive thyroid gland
- Impairment of brain function which is a serious complication of liver disease
- Loss of most of the fibers in optic nerve one, clouding of the cornea, involuntary eye movements
- Bullous photosensitivity
- A disease in which the body’s immune system attacks part of the peripheral nervous system
- Disturbances of the heart rhythm or conduction in the heart (sometimes life-threatening)
- life-threatening allergic reaction
- changes in the blood’s ability to clot
- allergic skin reactions (sometimes severe) including rapid swelling (edema) of the “leather skin” ( dermis ), subcutaneous tissue, mucous membranes and sub-mucosal tissue, itchy or sore patches of thick, red skin with silvery scales, irritation of the skin and mucous membranes, a life-threatening skin disease which causes large parts of the skin’s outermost layer ( epidermis ) to detach from the underlying skin layer
- small patches of dry and scaly skin, sometimes thickened with corn.
Adverse effects with no known frequency:
- freckles and pigment spots.
Other significant side effects whose frequency is not known, but which should be reported to your doctor immediately:
- Skin cancer
- Inflammation in tissue that surrounds the skeleton
- Red, scaly patches or ring-shaped skin changes may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Reactions have occasionally occurred while the infusion is in progress (redness, fever, sweating, palpitations, and shortness of breath). Your doctor may decide to stop the infusion if this happens.
Because voriconazole can affect the liver and kidneys, your doctor should check your liver and kidney function by taking blood tests. Tell your doctor if you have a stomach ache or if your stool has a different consistency.
Skin cancer has been reported in patients treated with voriconazole during long-term treatment.
Sun damage or severe skin reaction after exposure to light or sun was more common in children. If you or your child develop skin changes, the doctor may refer you to a dermatologist, who after consultation may decide that it is important for you or your child to have regular check-ups.
Elevated liver enzyme levels were also seen more often in children.
Tell your doctor if these side effects do not go away or are bothersome.
How to store Voriconazole Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
Unopened vial: This medicinal product does not require special storage instructions.
After dissolution (reconstitution), Voriconazole Fresenius Kabi should be used immediately, but if necessary can be stored for up to 24 hours at 2 °C – 8 °C (in a refrigerator). Reconstituted Voriconazole Fresenius Kabi must be diluted with the appropriate infusion fluid before infusing (See the end of this leaflet for further information).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines 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 voriconazole
- Other ingredients are hydroxypropylbetadex (MS 0.58-0.68), l- arginine, hydrochloric acid, and sodium hydroxide
Each vial contains 200 mg voriconazole, equivalent to 10 mg/ml solution, after reconstitution by the hospital pharmacist or nurse (see the end of this leaflet for further information).
Appearance and package sizes of the medicine
Voriconazole Fresenius Kabi packaged in a 25 ml glass vial in the form of a white or almost white freeze-dried powder for infusion solution, in packs of 1 or 20 vials per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi AB
751 74 Uppsala
Manufacturer
Fresenius Kabi Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg CEO
Germany