4 mg, 10 mg Lenvatinib hard capsules
What LENVIMA is and what it is used for
What LENVIMA is
LENVIMA is a medicine that contains the active substance lenvatinib. It is used alone to treat progressive or advanced thyroid cancer in adults when treatment with radioactive iodine has not been able to stop the disease.
LENVIMA can also be used alone to treat liver cancer (liver cell carcinoma) in adults who have not already been treated with another cancer drug given in the blood. As a patient, you will receive LENVIMA if your liver cancer has spread or cannot be removed by surgery.
LENVIMA can also be used with another cancer medicine called pembrolizumab to treat advanced cancer of the uterine lining ( endometrial cancer ) in adults whose cancer has spread after
they have previously been treated with another cancer drug via the bloodstream and
whose cancer cannot be removed by surgery or radiation therapy.
How LENVIMA works
LENVIMA blocks the effects of proteins called receptor thyrokinases (RTKs), which are involved in the development of new blood vessels that supply the cells with oxygen and nutrients and help them grow. These proteins can be present in large amounts in cancer cells and by blocking their effect, LENVIMA can slow down the rate at which the cancer cells multiply and the tumor grows and help to cut off the blood supply that the cancer cells need.
What you need to know before taking LENVIMA
Do not take LENVIMA
- if you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
- if you are breast-feeding (see the section below on Contraceptives, pregnancy and breast-feeding).
Warnings and cautions
Talk to your doctor before taking LENVIMA if you:
- have high blood pressure
- is a woman who may become pregnant (see the section below on Contraceptives, Pregnancy and Breastfeeding)
- have had heart problems or strokes
- have liver or kidney problems
- has recently undergone surgery or received radiation therapy
- to be operated on. Your doctor may consider stopping LENVIMA if you are having major surgery, as LENVIMA may affect wound healing. LENVIMA can be restarted when the wound has healed sufficiently.
- is over 75 years old
- belong to an ethnic group other than whites or Asians
- weighs less than 60 kg
- have previously had abnormal connections (called fistulas ) between different organs in the body or from one organ to the skin.
- if you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.
- have or have had pain in the mouth, teeth and / or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss . You may be advised to have a dental examination before starting LENVIMA as bone damage in the jaw ( osteonecrosis ) has been reported in patients treated with LENVIMA. If you need to have an invasive dental treatment or dental surgery, tell your dentist that you are being treated with LENVIMA, especially when you are also receiving or have been injected with bisphosphonates (used to treat or prevent bone diseases).
- may or have received certain medicines used to treat osteoporosis (antiresorptive medicines) or cancer medicines that alter the formation of blood vessels (so-called angiogenesis inhibitors), as the risk of bone damage in the jaw may increase.
Before you take LENVIMA, your doctor may check your blood pressure and take various samples, for example to check your liver or kidney function and to see if you have low salt levels and high levels of thyroid- stimulating hormone in your blood. Your doctor will discuss the results of these tests with you and determine if you can be treated with LENVIMA. You may need additional treatment with other medicines, take a lower dose of LENVIMA or be extra careful due to the increased risk of side effects .
If you are not sure, talk to your doctor before taking LENVIMA.
Children and young people
LENVIMA is not recommended for children and adolescents. The effects of LENVIMA in people younger than 18 years are not known.
Other medicines and LENVIMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to herbal preparations and over-the-counter medicines.
Contraceptives, pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- If you could become pregnant, use a very effective contraceptive while you are taking this medicine and for at least one month after stopping treatment. It is not known if LENVIMA can reduce the effect of birth control pills . If this is your normal method of contraception, you should therefore make sure that you also add a barrier method such as a diaphragm or condom if you have sex while you are being treated with LENVIMA.
- Do not take LENVIMA if you are planning to become pregnant during treatment, as it may seriously harm your baby.
- Tell your doctor immediately if you become pregnant while you are being treated with LENVIMA. Your doctor will help you decide whether to continue treatment.
- Do not breast-feed if you are taking LENVIMA, as the medicine passes into breast milk and can seriously harm your breast-fed baby.
Driving and using machines
LENVIMA can cause side effects that may affect your ability to drive or use machines. Avoid driving or using machines if you feel dizzy or tired.
How to take LENVIMA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
Thyroid cancer
- The recommended dose of LENVIMA is usually 24 mg once daily (2 10 mg capsules and 1 4 mg capsule).
- If you have severe liver or kidney problems, the recommended dose is 14 mg once a day (1 10 mg capsule and 1 4 mg capsule).
- Your doctor may reduce the dose if you have problems with side effects .
Liver cancer
- The recommended dose of LENVIMA depends on your body weight when you start treatment. One dose is usually 12 mg once daily (3 capsules of 4 mg) if you weigh 60 kg or more, and 8 mg once daily (2 capsules of 4 mg) if you weigh less than 60 kg.
- Your doctor may reduce the dose if you have problems with side effects .
Uterine cancer
- The recommended dose of LENVIMA is 20 mg once daily (2 10 mg capsules) in combination with pembrolizumab. Pembrolizumab is given by the doctor via injection into a vein, either 200 mg every three weeks or 400 mg every six weeks.
- Your doctor may reduce the dose if you have problems with side effects .
How to take this medicine
- You can take the capsules with or without food.
- Swallow the capsules whole with water or reconstituted. If you want to dissolve the capsules, measure a tablespoon of water or apple juice in a small glass and place the capsules without opening or tearing them. Let them lie for at least 10 minutes and then stir for at least 3 minutes so that the capsule shells dissolve properly. Drink mixture one. After drinking, add the same amount of water or apple juice again, spin the glass and swallow the liquid.
- Take the capsules at about the same time each day.
- Caregivers should not open the capsules to avoid repeated exposure to the contents of the capsule.
How long to take LENVIMA
You will usually continue to take this medicine for as long as you benefit from it.
If you take more LENVIMA than you should
If you have taken more LENVIMA than you should, talk to a doctor or pharmacist immediately. Take the medicine pack with you.
If you forget to take LENVIMA
Do not take a double dose (two doses at the same time) to compensate for a missed dose .
What to do if you forget to take your dose depends on how long it takes until the next dose .
- If it is 12 hours or more until the next dose: take the missed dose as soon as you remember. Then take the next dose at the usual time.
- If it is less than 12 hours until the next dose: skip the missed dose . Then take the next dose at the usual time.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects – you may need urgent medical attention:
- feeling stiff or weak on one side of the body, having severe headaches, seizures, confusion, difficulty speaking, changes in vision or dizziness – this may be a sign of a stroke , bleeding in the brain or effects on the brain with a sharp rise in blood pressure.
- pain or pressure in the chest, pain in the arms, back, neck or jaw, shortness of breath, rapid or irregular heart rate, cough, bluish color on lips or fingers, feeling very tired – this may be a sign of heart problems, a blood clot in the lungs or that it leaks air from the lung to the chest so that the lung is not filled.
- severe pain in the abdomen (abdomen) – this may be due to a hole in the intestinal wall or a fistula (a hole in the intestine which through a tube-like passage communicates with another part of the body or skin).
- black, tarry or bloody stools or coughing up of blood – this may be a sign of bleeding inside the body.
- yellow skin or yellowed whites of the eyes (jaundice) or drowsiness, confusion or poor concentration – these may be signs of liver problems.
- Diarrhea, nausea and vomiting – these are very common side effects that can be serious if they cause you to become dehydrated, which can lead to kidney failure . Your doctor may give you medicines to reduce these side effects .
- pain in the mouth, teeth and / or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss – this may be a sign of bone damage in the jaw ( osteonecrosis ).
Tell your doctor immediately if you notice any of the above side effects .
The following side effects may occur when this medicine is given alone:
Very common (may affect more than 1 in 10 people)
- high or low blood pressure
- loss of appetite or weight loss
- nausea and vomiting, constipation, diarrhea, abdominal pain, indigestion
- to feel very tired or weak
- huskiness
- swollen legs
- rash
- dry, sore or inflamed mouth, strange taste experience
- joint or muscle pain
- to feel dizzy
- hair loss
- bleeding (usually nosebleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or intestinal wall)
- difficulty sleeping
- changes in urine test results regarding protein (high) and urinary tract infections (increased urination frequency and painful urination)
- headache
- back pain
- redness , tenderness and swelling of the skin of the hands and feet ( palmar-plantar erythrodysesthesia )
- impaired thyroid function (fatigue, weight gain, constipation, chills, dry skin)
- changes in blood test results regarding potassium levels (low) and calcium levels (low)
- decreased white blood cell count
- changes in blood test results regarding liver function
- low levels of platelets in the blood which can lead to bruising and difficulty healing wounds.
- changes in blood test results regarding levels of magnesium in the blood (low), cholesterol (high) and levels of thyroid stimulating hormone (high)
- changes in blood test results regarding renal function and renal failure
- elevated lipase and amylase ( enzymes that are important for digestion)
Common (may affect up to 1 in 10 people)
- loss of body fluid (dehydration)
- palpitation
- dry skin, thickening of the skin and itchy skin
- bloating or gas problems
- heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
- liver failure
- drowsiness, confusion, poor concentration, loss of consciousness which may be signs of liver failure
- feeling sick
- inflammation of the gallbladder
- stroke
- anal fistula (a small canal that forms between the rectum and the surrounding skin)
Uncommon (may affect up to 1 in 100 people)
- painful infection or irritation near the anus
- ministroke
- liver damage
- severe pain in the upper abdomen (abdomen) which may be associated with fever, chills, nausea and vomiting (splenic infarction)
- inflammation of the pancreas
- wound healing problems
- bone injury in the jaw ( osteonecrosis ).
No known frequency (the following side effects have been reported after the introduction of LENVIMA but their frequency is unknown)
- other types of fistulas (an abnormal connection between different organs in the body or between the skin and an underlying structure such as the neck and trachea). The symptoms depend on the location of the fistula. Talk to your doctor if you experience any new or unusual symptoms such as coughing when you swallow.
- an enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
The following side effects may occur with this medicine when given in combination with pembrolizumab:
Very common (may affect more than 1 in 10 people)
- altered urine tests for protein (high levels) and urinary tract infections (increased urination frequency and pain when urinating)
- low levels of platelets in the blood, which can lead to bruising and difficulty in wound healing
- decreased white blood cell count
- decreased number of red blood cells
- underactive thyroid gland (fatigue, weight gain, constipation, frostbite, dry skin) and altered blood test results regarding thyroid stimulating hormone (high levels)
- overactive thyroid gland (symptoms may include rapid heartbeat , sweating and weight loss)
- altered blood test results regarding calcium levels (low levels)
- altered blood test results regarding potassium levels (low levels)
- altered blood test results regarding cholesterol levels (high levels)
- altered blood test results regarding magnesium levels (low levels)
- decreased appetite or weight loss
- dizziness
- headache
- back pain
- dry, sore or inflamed mouth, strange taste sensations
- bleeding (usually nosebleeds, but also other types of bleeding such as blood in the urine, bruising, gum bleeding or bleeding in the intestinal wall)
- high blood pressure
- huskiness
- nausea, vomiting, constipation, diarrhea, abdominal pain
- elevated amylase (digestive enzyme)
- elevated lipase (digestive enzyme)
- altered blood test results regarding liver function
- altered blood test results regarding renal function
- redness , tenderness and swelling of the skin on the hands and feet (palm plants erythrodysesthesia)
- rash
- joint or muscle pain
- great fatigue or weakness
- bone swelling
Common (may affect up to 1 in 10 people)
- dehydration
- difficulty sleeping
- palpitation
- low blood pressure
- blood clots in the lungs (difficulty breathing, chest pain)
- inflammation of the pancreas
- bloating or flatulence
- digestive problems
- inflammation of the gallbladder
- hair loss
- kidney failure
- feeling sick
Uncommon (may affect up to 1 in 100 people)
- headache, confusion, seizures and changes in vision
- signs of stroke such as numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision or dizziness
- mini- stroke ( TIA )
- signs of heart problems such as pain or pressure in the chest, pain in the arms, back, neck or jaw, shortness of breath, rapid or irregular heartbeat , cough, bluish color on lips or fingers and great tiredness
- severe breathing difficulties and chest pain caused by air leakage from the lung to the chest so that the lung can not be inflated
- painful infection or irritation near the rectal opening
- anal fistula (a small canal that forms between the rectal opening and the surrounding skin)
- liver failure or signs of liver damage such as yellow skin or yellow eye whites (jaundice) or drowsiness, confusion, poor concentration
- dry skin, thickening of the skin and itching
- wound healing problems
How to store LENVIMA
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and on each blister after “EXP”. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in the original blister pack. Moisture sensitive.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is lenvatinib.
- LENVIMA 4 mg hard capsules: Each hard capsule contains 4 mg lenvatinib (as mesilate).
- LENVIMA 10 mg hard capsules: Each hard capsule contains 10 mg lenvatinib (as mesilate).
- The other ingredients are calcium carbonate , mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose and talc. The capsule cover contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172). The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
What the medicine looks like and contents of the pack
- The 4 mg capsule has a yellow-red base and a yellow-red cap, approximately 14.3 mm long, marked with “Є” in black on the cap and “LENV 4 mg” on the base.
- The 10 mg capsule has a yellow base and a yellow-red cap, approximately 14.3 mm long, marked with “Є” in black on the cap and “LENV 10 mg” on the base.
- The capsules are delivered in blisters of polyamide / aluminum / PVC sealed with a printing foil of aluminum in cartons with 30, 60 or 90 hard capsules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
email: medinfo_de@eisai.net
Tilllve rkare
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany