Toctino

The usual starting dose of Toctino (Alitretinoin) is 30 mg taken once daily at the same time every day with a meal. People who experience severe side effects may find it necessary to reduce the dose to 10 mg daily. The 30 mg dose will cause the skin to clear faster, but both strengths work to clear the skin.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Toctino (Alitretinoin) should be taken with food, preferably with a main meal.

Toctino (Alitretinoin) is usually taken for 12 to 24 weeks depending on your response. If your eczema is still severe after 12 weeks, discuss with your doctor whether continuing the medication will improve your skin.

It is important to take Toctino (Alitretinoin) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Toctino (Alitretinoin) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause redness of the face; it may increase the amount of cholesterol in your blood; it may cause chapped lips; it may cause nausea or, rarely, vomiting; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; it can cause dryness of the skin. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

10 mg capsule
Each soft, brown, oval capsule contains 10 mg of Toctino (Alitretinoin). Nonmedicinal ingredients: soybean oil, partially hydrogenated soybean oil, medium chain triglycerides, yellow wax, and DL-alpha-tocopherol. The capsule shell contains: gelatin, glycerol, sorbitol, water, iron oxide red, and iron oxide black.

30 mg capsule
Each soft, brown, oval capsule contains 30 mg of Toctino (Alitretinoin). Nonmedicinal ingredients: soybean oil, partially hydrogenated soybean oil, medium chain triglycerides, yellow wax, and DL-alpha-tocopherol. The capsule shell contains: gelatin, glycerol, sorbitol, water, iron oxide red, and iron oxide yellow.

Do not take Toctino (Alitretinoin) if you:

• are allergic to Toctino (Alitretinoin), other retinoids (e.g., Isotretinoin), or any ingredients of the medication
• are allergic to peanuts or soya
• are breast-feeding
• are under 18 years of age
• are pregnant
• are taking Tetracycline antibiotics (e.g., tetracycline, doxycycline, Minocycline)
• have fructose intolerance
• have High Cholesterol and/or triglyceride blood levels
• have reduced liver function
• have reduced Thyroid function that is not being treated
• have severe Kidney Disease
• have very high levels of vitamin A

Toctino (Alitretinoin) should not be taken by women who may become pregnant unless ALL of the following conditions apply:

• You have severe chronic hand eczema that has not responded to high potency topical corticosteroids.
• You are reliable in understanding and carrying out instructions.
• You are able and willing to comply with the mandatory birth control measures for at least one month before, during, and at least one month after treatment.
• You have received, and acknowledged understanding of, a careful oral and printed explanation of the hazards of fetal exposure to Toctino (Alitretinoin), and the risk of possible birth control failure.
• You have been informed and understand the need to quickly consult your doctor if there is a risk that you may be pregnant.
• You understand the need for strict monthly follow-up with regular monthly pregnancy tests.
• You use effective birth control without any interruption for one month before, during, and for one month after stopping Toctino (Alitretinoin). You are aware that 2 reliable forms of birth control should be used at the same time without interruption including a barrier method.
• You have had two blood or urine pregnancy tests with negative results, performed in a licensed laboratory, at least 3 weeks apart, before beginning treatment on Toctino (Alitretinoin). You have had 2 or 3 days of your next normal menstrual period before Toctino (Alitretinoin) therapy is initiated.
• Take a pregnancy test at your doctor’s office one month after stopping treatment with Toctino (Alitretinoin).
• If you require additional treatment with Toctino (Alitretinoin) in the future, you must also follow the same requirement for birth control before, during and after taking Toctino (Alitretinoin).
• Your doctor has counselled you using the TOCTINO Pregnancy Prevention Program which includes detailed information about Toctino (Alitretinoin), a checklist of the above conditions, detailed information on birth control options, and a consent form for your review and signature.

There may be an interaction between Toctino (Alitretinoin) and any of the following:

• Abiraterone
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• birth control pills (estrogens and progestins)
• Carbamazepine
• Cobicistat
• conivaptan
• delavirdine
• Gemfibrozil
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• idelalasib
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methotrexate
• mifepristone
• multivitamins/minerals (with vitamins A, D, E, or K; folate; or iron)
• Palbociclib
• porfimir
• progestin-only birth control
• ritonavir
• tetracycline antibiotics (tetracycline, doxycycline, minocycline)
• vitamin A or other retinoids

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Toctino (Alitretinoin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Toctino (Alitretinoin).

Blood donation: You should not give blood during treatment with Toctino (Alitretinoin) and for one month after stopping treatment in case the blood is given to a pregnant woman.

Bones and joints: Toctino (Alitretinoin) may cause some minor bone changes. Talk to your doctor if you notice aches or pains in the bones or joints, or have difficulty moving. Your doctor may monitor you for bone changes while you are taking Toctino (Alitretinoin).

Cholesterol: Toctino (Alitretinoin) can cause increases in cholesterol and other lipids in the blood. If you are already at an increased risk of developing high cholesterol, for example if you have a family history of high cholesterol, Diabetes, are overweight, or have an increased alcohol intake, you are more likely to experience this.

If you are at any increased risk of developing increased blood lipids, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed.

Depression and suicidal thoughts: Retinoid medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Toctino (Alitretinoin), contact your doctor as soon as possible.

Diabetes: Toctino (Alitretinoin) may cause a loss of control of blood sugar levels for people with diabetes. If you have diabetes, or anyone in your family has diabetes, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

Stomach and bowels: Toctino (Alitretinoin) may cause inflammatory bowel disease (IBD). If you have inflammatory bowel disease, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed.

If you experience severe abdominal pain, rectal bleeding, or severe diarrhea, you should stop using Toctino (Alitretinoin) and contact your doctor.

Liver function: Retinoids like Toctino (Alitretinoin) have been linked to inflammation of the liver in some cases. If you have liver problems, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Toctino (Alitretinoin).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor as soon as possible.

Neurologic effects: Toctino (Alitretinoin) has been linked to causing intracranial hypertension (increased pressure around the brain), also known as pseudotumor cerebri. Early symptoms of this condition include headache, nausea, vomiting, and visual disturbances. If you have these symptoms call your doctor immediately.

Skin care: Toctino (Alitretinoin) causes irritated, dry skin and lips. Ask your doctor or pharmacist for appropriate moisturizers and lip balms to use to prevent severe dryness. While you are taking Toctino (Alitretinoin), avoid exfoliators, waxing, and dermabrasion.

Sun sensitivity: Toctino (Alitretinoin) may make you more likely to burn in the sun. Use appropriate measures to prevent excessive exposure to the sun. Wear a hat and sunglasses when out in the sun, use a sunscreen that provides an SPF of 30 or higher, and avoid going out in the sun between 10 am and 2 pm when the sun is at its strongest. Avoid using sun lamps and tanning beds.

Thyroid disease: Toctino (Alitretinoin) may cause changes in thyroid function. The thyroid gland produces hormones that help the body make energy and organs work properly. If you experience unexpected fatigue, intolerance to cold or weight gain, contact your doctor as soon as possible. If you have thyroid problems, discuss with your doctor how Toctino (Alitretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Toctino (Alitretinoin), and whether any special monitoring is needed. Your doctor may want to test your thyroid function regularly with blood tests while you are taking Toctino (Alitretinoin).

Vision: Toctino (Alitretinoin) may cause dry eyes. This usually disappears after stopping the medication. Using a lubricating eye drop may help with this side effect. Also, decreased night vision has been reported by people taking Toctino (Alitretinoin) . This may happen suddenly and without warning. Use caution when driving or operating any vehicle at night. Report any night vision changes to your doctor. Stop taking the medication and seek immediate medical attention if you notice other signs of vision changes, such as blurred vision, distorted vision, or a cloudy surface on the eye.

Vitamin supplements: You should not take vitamin supplements containing vitamin A if you also take Toctino (Alitretinoin) as this may increase the side effects of vitamin A. Talk to your doctor or pharmacist if you are not sure which of your supplements might contain vitamin A.

Pregnancy: Toctino (Alitretinoin) causes severe birth defects in an extremely high percentage of infants born to women who take Toctino (Alitretinoin) even for a short period of time during pregnancy.

Toctino (Alitretinoin) must not be used during pregnancy. Women must not become pregnant while taking Toctino (Alitretinoin) or for at least one month after stopping the medication. Your doctor may perform monthly pregnancy tests while you are taking Toctino (Alitretinoin) to confirm the safety of continuing to take Toctino (Alitretinoin).

Women who may become pregnant must not be given Toctino (Alitretinoin) until pregnancy is excluded. A pregnancy test must be performed at the initial assessment appointment with your doctor. A second pregnancy test must be performed within 11 days of starting treatment. Toctino (Alitretinoin) treatment should start on the second or third day of the next normal menstrual period following this negative pregnancy test. Effective birth control must be used for at least one month before starting Toctino (Alitretinoin) treatment, during the treatment, and for at least one month following the discontinuation of treatment.

Two reliable forms of birth control should be used at the same time during treatment unless abstinence is the chosen method.

Breast-feeding: It is likely that Toctino (Alitretinoin) passes into breast milk. If you are a breast-feeding mother and are taking Toctino (Alitretinoin), it may harm your baby. Women who are taking Toctino (Alitretinoin) must not breast-feed.

Children: The safety and effectiveness of using Toctino (Alitretinoin) have not been established for children. Toctino (Alitretinoin) is not recommended for use if you are under the age of 18.

Seniors: The use of Toctino (Alitretinoin) by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from Toctino (Alitretinoin).

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Avoid taking vitamin A supplements while using this medication. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication is more effective if taken with food. Always take it with a meal or a snack.