100 mg soft capsules
nintedanib
What Vargatef is and what it is used for
Vargatef capsules contain the active substance nintedanib. Nintedanib blocks the activity of a group of proteins involved in the formation of new blood vessels, which cancer cells need to get blood and oxygen. By blocking the activity of the proteins, nintedanib can stop the growth and spread of the cancer tumor.
This medicine is used in combination with another cancer medicine (docetaxel) to treat a type of cancer in the lungs called non-small cell lung cancer (NSCLC). It is intended for adult patients who have a certain type of NSCLC (” adenocarcinoma “), and who have already received a treatment cycle with another medicine against this cancer, but where the tumor has started to grow again.
What you need to know before you take Vargatef
Do not take Vargatef:
- if you are allergic to nintedanib, peanuts or soya, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Vargatef
- if you have or have had liver problems if you have or have had bleeding problems, especially if you have recently had a lung bleed
- if you have or have had kidney problems or if an increased amount of protein has been detected in the urine ( proteinuria )
- if you take blood-thinning medicines (eg warfarin, phenprocoumon, heparin, or aspirin ) to prevent blood clots. Treatment with Vargatef may lead to an increased risk of bleeding
- if you have recently had surgery or are about to undergo surgery. Nintedanib may affect wound healing. Therefore, a break-in treatment with Vargatef is usually done before an operation. Your doctor will decide when to resume treatment with this medicine.
- if you have cancer that has spread to the brain
- if you have high blood pressure
- if you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall
When your doctor receives this information, he/she may take blood samples, for example, to check your liver function and to determine how quickly your blood can clot. The doctor will discuss the results of the tests with you and decide whether you can receive Vargatef.
When you take the medicine, tell your doctor immediately about
- you get diarrhea. Treatment must be started at the first sign of diarrhea (see section 4)
- you vomit or feel sick (nausea)
- if you have unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, right-sided pain in the upper part of the stomach (abdomen), increased tendency to bleed or bruise, or feeling tired. This could be a sign of serious liver problems
- if you develop a fever, chills, fast heartbeat, or feel short of breath. These may be signs of infection or blood poisoning ( sepsis ) (see section 4)
- if you experience severe pain in the stomach, fever, chills, nausea, vomiting, hard abdominal wall, or feeling of bloating, as these may be symptoms of a hole in the intestinal wall (“gastrointestinal perforation”)
- if you experience pain, swelling, redness, warmth in an arm or leg or if you experience chest pain and difficulty breathing, as these may be symptoms of a blood clot in a vein
- if you have a major bleed
- if you feel pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder, or arm, fast heartbeat, shortness of breath, nausea, or vomiting, as these may be symptoms of a heart attack
- if any of the side effects you may get (see section 4) become serious
Children and young people
This medicine has not been studied in children and adolescents and is therefore not intended for use by children and adolescents under the age of 18.
Other medicines and Vargatef
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal and non-prescription medicines.
This medicine may interfere, or be interfered with, with some other medicines. The following medicines may increase the blood levels of nintedanib, the active substance in Vargatef, and thus increase the risk of side effects (see section 4):
- Ketoconazole (used for fungal infections)
- Erythromycin (used against bacterial infections)
The following medicines can lower the blood levels of nintedanib and thus cause Vargatef to be less effective:
- Rifampicin (an antibiotic used for tuberculosis )
- Carbamazepine, phenytoin (used for seizures)
- John’s wort (a (traditional) herbal remedy for mild depression)
Pregnancy, breastfeeding, and fertility
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.
Pregnancy
Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.
Contraceptive
- Women who could become pregnant must use highly effective contraception to prevent pregnancy when they start taking Vargatef, while they are taking Vargatef, and for at least 3 months after they stop treatment.
- You should discuss with your doctor which contraceptives are best for you.
- Vomiting and/or diarrhea or other gastrointestinal complaints can affect the absorption of hormonal contraceptives taken by mouth, e.g. birth control pills, and can reduce their effect. If you experience these conditions, you should therefore speak to your doctor to discuss an alternative, more suitable method of contraception.
- Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Vargatef.
Breast-feeding
It is not known whether the drug passes into breast milk and could harm a nursing baby. Therefore, women must not breastfeed while being treated with Vargatef.
Fertility
The effect of this medicine on human fertility has not been studied.
Driving ability and use of machinery
Vargatef may have a minor effect on the ability to drive and use machines. You should not drive or operate machinery if you feel ill.
Vargatef contains soy
The capsules contain soy lecithin. If you are allergic to peanuts or soya, you should not use this medicine.
How to take Vargatef
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Do not take Vargatef on the same day as your docetaxel chemotherapy treatment.
Swallow the capsules whole with water. You must not chew them. The recommendation is that you take the capsules with food, that is, during or immediately before or after a meal.
The capsule must not be opened or crushed (see section 5).
The recommended dose is four capsules per day (that is, a total of 400 mg of nintedanib per day). Do not take more than that one dose.
This daily dose should be divided into two doses of two capsules approximately 12 hours apart, for example, two capsules in the morning and two capsules in the evening. Take both of these doses at about the same time each day. By taking the medicine in this way, you are sure to always have an even amount of nintedanib in your body.
Dose reduction
If you cannot tolerate the recommended dose of 400 mg per day due to side effects (see section 4), your doctor may reduce the daily dose of Vargatef. Do not reduce the dose or stop the treatment yourself without first consulting your doctor!
Your doctor may reduce your recommended dose to 300 mg per day (two 150 mg capsules). In that case, the doctor prescribes Vargatef 150 mg soft capsules for your treatment.
If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg each). If that happens, the doctor will prescribe the correct capsule strength.
In either case, take one capsule of the correct strength twice daily, approximately 12 hours apart, with food (for example, in the morning and the evening) at approximately the same time each day.
If your doctor has stopped your chemotherapy with docetaxel, you should continue to take Vargatef twice a day.
If you have taken too much Vargatef
Contact a doctor or pharmacist immediately.
If you forget to take Vargatef
Do not take a double dose to make up for a missed dose. Take the next dose of Vargatef as planned at the next regular time and in the dose recommended by the doctor or pharmacist.
If you stop taking Vargatef
Do not stop taking Vargatef without first talking to your doctor. You must take this medicine every day, as long as your doctor prescribes it. If you do not take this medicine as directed by your doctor, this cancer treatment may not work as it should.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must pay particular attention if you experience the following side effects during treatment with Vargatef:
- Diarrhea (very common, may affect more than 1 in 10 users):
Diarrhea can cause the body to lose fluids and important salts ( electrolytes, such as sodium or potassium ). At the first sign of diarrhea, drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrheal therapy, e.g. with loperamide, as soon as possible after you have contacted the doctor.
- Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people ):
Treatment with Vargatef can lead to a reduced number of a certain type of white blood cells ( neutropenia ). These are cells that are important for the body’s defense against bacterial and fungal infections. As a result of neutropenia, one can get a fever ( febrile neutropenia ) and blood poisoning ( sepsis ). Tell your doctor immediately if you develop a fever, chills, fast heartbeat, or feel short of breath.
During treatment with Vargatef, your doctor will regularly check your blood and examine you to see if you have any signs of infection, such as inflammation, fever, or fatigue.
The following side effects were observed during treatment with this medicine:
Very common side effects (may affect more than 1 in 10 users )
- Diarrhea – see above
- Painful numbness and/or tingling in fingers and toes ( peripheral neuropathy )
- Nausea
- Vomiting
- Pain in the abdomen
- Bleeding
- Decrease in the number of white blood cells ( neutropenia )
- Inflammation of the mucous membranes of the digestive tract, including various types of ulcers in the mouth ( mucositis, including stomatitis )
- Rash
- Decreased appetite
- Electrolyte imbalance (impaired salt levels)
- Elevated liver enzyme levels (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase in the blood) in the blood, which can be seen in blood tests
- Hair loss (alopecia)
Common side effects (may affect up to 1 in 10 users )
- Blood poisoning ( sepsis ) – see above
- Decrease in the number of white blood cells combined with fever ( febrile neutropenia )
- Blood clots in the veins ( venous thromboembolism ), especially in the legs (symptoms include pain, redness, swelling, and warmth in an arm or leg), can travel via blood vessels to the lungs and cause chest pain and difficulty breathing (see a doctor immediately if you notice any of these symptoms)
- High blood pressure ( hypertension )
- Fluid loss ( dehydration )
- Abscesses _
- Low platelet count ( thrombocytopenia )
- Jaundice ( hyperbilirubinemia )
- Elevated liver enzyme levels (gamma-glutamyltransferase) in the blood, which can be seen in blood tests
- Weight loss
- Itching
- Headache
- The increased amount of protein in the urine ( proteinuria )
Uncommon side effects (may affect up to 1 in 100 users)
- That a hole occurs in the intestinal wall ( gastrointestinal perforation )
- Severe liver problems
- Inflammation of the pancreas ( pancreatitis )
- Myocardial infarction
- Kidney failure
Has been reported (occurring in an unknown number of users)
- Inflammation of the colon
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections)
How Vargatef should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton, outer cover, and blister. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Store in the original packaging. Moisture sensitive.
Do not use this medicine if you notice that the blister containing the capsules has been opened or that a capsule is broken.
If you come into contact with the contents of the capsule, wash your hands immediately with plenty of water (see section 3).
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 nintedanib. Each soft capsule contains 100 mg of nintedanib (as besylate).
The auxiliary substances are:
Capsule content: Triglyceride er, medium chains; hard fat, soy lecithin (E322)
Capsule shell: Gelatin, glycerol (85%), titanium dioxide (E171), red iron oxide (E172),
yellow iron oxide (E172)
Printing ink: Shellac, black iron oxide (E172), propylene glycol (E1520)
Appearance and package sizes of the medicine
Vargatef 100 mg soft capsules (capsules) are peach-colored, opaque, oblong capsules with the Boehringer Ingelheim corporate symbol and “100” printed in black on one side.
There are three different pack sizes of Vargatef 100 mg soft capsules:
- A carton containing 60 capsules (6 aluminum blisters each containing 10 capsules).
- A carton containing 120 capsules (12 aluminum blisters each containing 10 capsules).
- A multipack containing 120 capsules (2 cartons of 60 capsules each held together by a wrapper).
Not all pack sizes of Vargatef 100 mg soft capsules may be marketed.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienSCS Boehringer Ingelheim Comm.VTél/Tel: +32 2 773 33 11 | LithuaniaBoehringer Ingelheim RCV GmbH & Co KGLietuvos filialasPhone: +370 5 2595942 |
| BulgariaBjöringer Ingelheim РЦВ ГмбХ и Ко. KG – clone Bulgaria phone: +359 2 958 79 98 | Luxembourg/LuxembourgSCS Boehringer Ingelheim Comm.VTél/Tel: +32 2 773 33 11 |
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