Alitretinoin Douglas Special Precautions

Possible risk of neuropsychiatric disorders.
Pregnancy and prevention programme: Women who are pregnant must not take Alitretinoin: This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Alitretinoin is taken only for a short time during pregnancy.
The patient must not take Alitretinoin if she is pregnant or if the patient thinks she might be pregnant.
The patient must not take Alitretinoin if she is breastfeeding. The medicine is likely to pass into the milk and may harm the baby.
The patient must not take Alitretinoin if she could get pregnant during treatment.
The patient must not get pregnant for one month after stopping this treatment because some medicine may still be left in the body.
Women who could get pregnant are prescribed Alitretinoin under strict rules. This is because of the risk of serious harm to the unborn baby: These are the rules: The doctor must explain the risk of harm to the unborn baby - the patient must understand why she must not get pregnant and what she needs to do to prevent getting pregnant.
The patient must have talked about contraception (birth control) with a doctor. The doctor will give information on how not to get pregnant. The doctor may send a specialist for contraception advice.
Before starting the treatment, the doctor will ask the patient to take a pregnancy test. The test must show that the patient is not pregnant when starting treatment with Alitretinoin.
Women must use effective contraception before, during and after taking Alitretinoin: The patient must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with a doctor which methods would be suitable for the patient.
The patient must use contraception for a month before taking Alitretinoin, during treatment and for a month afterwards.
The patient must use contraception even if she does not have periods or she is not sexually active (unless the doctor decides this is not necessary).
Women must agree to pregnancy testing before, during and after taking Alitretinoin: The patient must agree to regular follow-up visits, ideally every month.
The patient must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in the body, 1 month after stopping Alitretinoin (unless the doctor decides it is not necessary in this case).
The patient must agree to extra pregnancy tests if the doctor asks her.
The patient must not get pregnant during treatment or for a month afterwards because some medicine may still be left in the body.
The doctor will discuss all these points with the patient, using a checklist and will ask the patient (or a parent/guardian) to sign it. This form confirms that the patient had been told about the risks and that the patient will follow the rules previously mentioned.
If the patient gets pregnant while taking Alitretinoin, stop taking the medicine straight away, and contact a doctor. The doctor may send the patient to a specialist for advice.
Also, if the patient becomes pregnant within one month after she stopped taking Alitretinoin, the patient should contact a doctor. The doctor may send the patient to a specialist for advice.
Advice for men: The levels of oral retinoid in the semen of men taking Alitretinoin are too low to harm their partners' unborn baby. However, the patient must never share the medication with anyone.
Additional precautions: The patient should never give this medicinal product to another person. Please take any unused capsules to a pharmacist at the end of treatment.
The patient should not donate blood during treatment with this medicine and for 1 month after stopping Alitretinoin because an unborn baby could be harmed if a pregnant patient receives the blood.
Talk to a doctor or pharmacist before taking Alitretinoin: If the patient ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting self or ending life. This is because, mood may be affected while taking Alitretinoin.
If the patient has kidney disease. Alitretinoin is not recommended for people with moderate kidney disease. If the patient has kidney disease - check with a doctor if Alitretinoin is suitable for the patient.
If the patient has high blood fats, the patient may need blood tests more often. Alitretinoin commonly increases blood fats, such as cholesterol or triglycerides. If the patient's blood fats stay high, the doctor may lower the dose, or take off the Alitretinoin.
If the patient has high blood sugar (diabetes), the patient's blood sugar levels may need to be checked more often and the doctor may start on a lower dose of Alitretinoin.
If the patient has been suffering from thyroid disease. Alitretinoin may lower the patient's thyroid hormone levels. If the patient's thyroid hormone level is low, the doctor may prescribe supplements.
The patient needs to take care during treatment: If the patient experiences any problems with sight, tell a doctor immediately. Alitretinoin may need to be stopped and patient's sight monitored.
If the patient gets a persistent headache, nausea or vomiting (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension.
Stop the capsules immediately and contact a doctor as soon as possible.
If the patient has bloody diarrhoea stop the capsules immediately and contact a doctor as soon as possible.
Minimise patient's exposure to sunlight and avoid sun lamps. Patient's skin may become more sensitive to sunlight. Before the patient goes out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher). If the patient gets dry skin and lips during treatment, use a moisturising ointment or cream and a lip balm.
Cut down on intensive physical exercise: alitretinoin can cause muscle and joint pain.
If the patient develops dry eyes, lubricating eye ointment or tear replacement drops can help. If the patient wears contact lenses, the patient may need to wear glasses during alitretinoin treatment. Dry eyes and sight problems normally return to normal once treatment is stopped.
Alitretinoin may increase liver enzyme levels. The doctor will do blood tests during treatment to check these levels. If they stay high, the doctor may lower the dose or take off the Alitretinoin.
Mental health problems: The patient may not notice some changes in mood and behaviour and so it is very important to tell friends and family that the patient is taking this medicine. They may notice these changes and help the patient quickly identify any problems that the patient needs to talk to the doctor about.
If the patient develops any mental health problems including depression, aggressive tendencies, mood changes, thoughts about hurting self or ending life, the patient must stop taking Alitretinoin immediately and contact a doctor as soon as possible.
Other medicines and Alitretinoin: Do not take other retinoid medicines (e.g. isotretinoin), vitamin A supplements or tetracyclines (a type of antibiotic) while taking Alitretinoin. This increases the risk of side effects.
Tell a doctor or pharmacist if: The patient is taking amiodarone (a medicine that helps to regulate heart rate). Amiodarone is not recommended to be taken together with Alitretinoin.
The patient is taking ketoconazole, fluconazole, miconazole (medicines used to treat infections). The doctor may decide to reduce the dose of Alitretinoin.
The patient is taking simvastatin (a medicine used to lower cholesterol). Alitretinoin may decrease the amount of this medicine in the body.
The patient is taking gemfibrozil (another medicine used to lower cholesterol) or oxandrolone (an anabolic steroid). The doctor may decide to reduce the dose of Alitretinoin.
The patient is taking paclitaxel (used to treat cancer), rosiglitazone or repaglinide (used to treat diabetes). Alitretinoin may increase the amount of these medicines in the body.
Tell a doctor or a pharmacist if the patient is taking, or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.
Alitretinoin capsules contains soya oil: If the patient is allergic to peanut or soya, do not use this medicinal product.
Alitretinoin capsules contains sorbitol: This medicine contains 13.28 mg sorbitol in each capsule.
Driving and using machines: The patient may not see as well at night during the treatment. If this happens, the patient should not drive or operate machinery.
Use in Children and Adolescents: Alitretinoin is not recommended for people aged under 18 years old. It is not known how well it works in this age group.