What Targretin is and what it is used for
The active substance in Targretin is bexarotene. The substance belongs to a group of medicines called retinoids which are similar to vitamin A. Targretin capsules are used by patients with advanced-stage cutaneous T-cell lymphoma (CTCL), whose disease has not responded to other treatments. CTCL is a disease in which certain cells in the body’s lymphatic system, the so-called T-lymphocytes, become cancerous and attack the skin.
What you need to know before taking Targretin
Do not take Targretin
- if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding or if you may become pregnant and are not using effective contraception.
- if you have previously had pancreatitis, have high blood cholesterol or blood triglyceride levels, have something called hypervitaminosis A, have uncontrolled thyroid disease, have an insufficient liver function, or have an ongoing systemic infection.
Warnings and precautions
Talk to your doctor before taking Targretin:
- if you are hypersensitive to retinoids (similar to vitamin A), if you have liver disease if you have high blood lipid levels or take medicines that can cause high blood lipid levels, have uncontrolled diabetes mellitus (diabetes), have had problems with the gallbladder or bile ducts or drink large amounts of alcohol.
- if you have ever had problems with your mental health, including depression, aggressive tendencies, and mood swings. Targretin can affect your mood.
If necessary, determination of blood lipids on an empty stomach must be done, before starting the treatment and at one-week intervals and then every month while you are taking this medication.
Before treatment begins and during treatment, blood tests are also taken to assess the function of your liver and thyroid gland and to check your red and white blood cells.
Regular eye exams may be needed if you experience vision problems while taking this medicine.
Avoid sunlight and tanning beds as much as possible.
Do not take more than 15,000 international units of vitamin A supplements per day during treatment.
Mental health problems
You may not notice some changes in your mood and behavior yourself, so you must tell your friends and family that this medicine may affect your mood and behavior. They can notice these changes and help you identify any problems that you need to talk to your doctor about.
Children and young people
Targretin capsules should not be used in children or adolescents.
Other medicines and Targretin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines, such as
- ketoconazole and itraconazole (used against fungal infections),
- erythromycin, clarithromycin, and rifampicin (used against bacterial infections),
- phenytoin and phenobarbital (used for seizures),
- gemfibrozil (used against high blood fat levels such as triglycerides and cholesterol ),
- vitamin A supplements, protease inhibitors (used against viral infections),
- tamoxifen (used to treat certain cancers),
- dexamethasone (used for inflammation ),
- insulin, drugs that increase insulin secretion or insulin-enhancing agents (used in diabetes ).
This is important because using more than one drug at the same time can strengthen or weaken their effect.
Targretin with food and drink
Targretin should be taken with food (see section 3). If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor, as this may change your body’s response to Targretin treatment.
Pregnancy and breastfeeding
Targretin may be harmful to a developing fetus. Do NOT take Targretin if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
If you can become pregnant, a pregnancy test must be done during the week before starting treatment to make sure you are not pregnant. You must use effective contraception during the entire treatment period and for one month before and after treatment. It is recommended that you use two types of contraception at the same time. If you are taking a hormonal contraceptive (for example, the pill ), you should discuss this with your doctor.
If you are male and your partner is pregnant or may become pregnant, you must use a condom during intercourse while taking bexarotene and for at least one month after the last dose.
Driving ability and use of machinery
It is not known whether Targretin affects your ability to drive and use machines. If you feel dizzy or have vision problems during the treatment, you should not drive a car or use machinery.
Targretin contains sorbitol and butyl hydroxyanisole
Targretin contains a small amount of sorbitol (a type of sugar). If you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Butylhydroxyanisole, which is part of Targretin, can irritate the mucous membranes. Therefore, the capsules should be swallowed whole without chewing.
How to take Targretin
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor will prescribe an appropriate dose for you.
The recommended dose is usually 4 to 10 capsules to be taken once a day. Take the prescribed number of capsules at the same time each day with a meal. You can take the capsules immediately before, during, or immediately after a meal. The capsules should be swallowed whole and not chewed.
How long you should take Targretin
Some patients get better in the first few weeks of treatment, but most need several months to feel better.
If you have used too much Targretin
If you have taken more Targretin than the prescribed dose, you must contact your doctor.
If you forget to take Targretin
If you have forgotten to take a dose, take the daily dose at the next meal on the same day and take the usual dose as normal the next day. Do not take a double dose one day to make up for a missed dose the day before.
If you stop taking Targretin
Your doctor will decide how long you should take Targretin and when treatment can be stopped. Do not stop taking your medicine until your doctor says you can.
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. Tell your doctor as soon as possible if you feel worse while taking Targretin. Sometimes it becomes necessary to change the dose or stop the treatment. Your doctor will tell you what to do.
The following side effects have been observed in patients with CTCL treated with the recommended initial dose of capsules.
Very common (may affect more than 1 in 10 patients treated):
Low white blood cell count.
Reduction of thyroid hormone.
High blood fat values (triglycerides and cholesterol ).
Skin reactions ( itching, redness, irritation, scaling).
Headache, fatigue, pain.
Common (may affect up to 1 in 10 treated patients):
The low value of red blood cells, enlarged lymph nodes, worsening of lymphoma.
Thyroid problems.
High liver enzyme values, reduced kidney function, low blood protein value, and weight gain.
Insomnia, dizziness, and reduced skin sensation.
Dry eyes, deafness, abnormal sensations from the eyes such as irritation and feeling of heaviness.
Swelling of legs and arms.
Nausea, diarrhea, dry mouth, dry lips, loss of appetite, constipation, flatulence, abnormal liver function values, vomiting.
Dry skin, skin problems, hair loss, skin ulcers, acne, thicker skin, skin nodules, and increased sweating.
Joint pain, bone pain, muscle pain.
Chills, abdominal pain, allergic reaction, infection.
Uncommon (may affect up to 1 in 100 patients treated):
Blood disorder, eosinophilia, leukocytosis, lymphocytosis, purpura, high or low platelet count.
Overactive thyroid gland.
Increased bilirubin in the blood, impaired kidney function, gout, and reduced HDL cholesterol.
Restlessness, balance difficulties, depression, heightened skin sensation, abnormal nerve sensations, vertigo.
Abnormal vision, blurred vision, inflammation of the eyelids, cataracts, inflammation of the whites of the eyes, damage to the cornea, hearing problems, and visual field defects.
Swelling, bleeding, high blood pressure, high heart rate, noticeable vein enlargement, and dilation of blood vessels.
Gastrointestinal disorders, liver failure, inflammation of the pancreas.
Hair changes, herpes simplex, nail problems, pustular rash, serous drainage, skin discoloration.
Muscle weakness.
Protein in urine, abnormal kidney function.
Back pain, skin infection, fever, parasitic infection, abnormal laboratory test values, mucosal disorders, tumor.
Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.
If you get side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
How to store Targretin
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.
Store at a maximum of 30°C. Close the bottle well.
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
Each Targretin capsule contains 75 mg of the active substance bexarotene. The capsules also contain the excipients macrogol, polysorbate, povidone, and butyl hydroxyanisole.
The capsule shell consists of gelatin, sorbitol, and glycerin mixture (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol, and water), titanium dioxide (E171) and ink (SDA-35A alcohol ( ethanol and ethyl acetate), propylene glycol (E1520), black iron oxide (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
Appearance and package sizes of the medicine
Targretin is supplied as soft capsules for oral intake, in a white plastic container containing 100 capsules.
Marketing Authorisation Holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
e-mail: medinfo_de@eisai.net
Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany