Hanzema

Brand Name

Hanzema

Common Name

alitretinoin

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Alitretinoin is a vitamin A derivative that belongs to the class of medications called retinoids. Retinoids are usually used to treat skin problems. Alitretinoin is used to treat severe chronic hand eczema that has not responded to other measures such as protecting the skin, avoiding irritants and allergens (triggers) and the use of high potency topical corticosteroids. It may take 2 months to notice improvement of skin symptoms.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual starting dose of 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.

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

This medication 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 this medication 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 this medication 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.

What form(s) does this medication come in?

10 mg
Each opaque, brown, oval, soft gelatin capsule, imprinted with R6 in white ink, contains 10 mg of alitretinoin. Nonmedicinal ingredients: DL-α-tocopherol, gelatin, glycerin, medium chain triglycerides, glyceryl distearate, glyceryl monooleate, sorbitol, soybean oil, water, iron oxide red, and iron oxide black. Imprinting ink: Opacode® S-1-7085 white (shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone).

30 mg
Each opaque, red-brown, oval, soft gelatin capsule, imprinted with R7 in white ink, contains 30 mg of alitretinoin. Nonmedical ingredients: DL-α-tocopherol, gelatin, glycerin, medium chain triglycerides, glyceryl distearate, glyceryl monooleate, sorbitol, soybean oil, water, iron oxide red, and iron oxide yellow.

Imprinting ink: Opacode® S-1-7085 white (shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone).

Who should NOT take this medication?

Do not take alitretinoin if you:

• are allergic to 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

Alitretinoin should not be taken by people 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 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 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 2 blood or urine pregnancy tests with negative results, performed in a licensed laboratory, at least 3 weeks apart, before beginning treatment on this medication. You have had 2 or 3 days of your next normal menstrual period before alitretinoin therapy is initiated.
• Take a pregnancy test at your doctor’s office one month after stopping treatment with alitretinoin.
• If you require additional treatment with alitretinoin in the future, you must also follow the same requirement for birth control before, during and after taking alitretinoin.
• Your doctor has counselled you using the Hanzema Pregnancy Prevention Program which includes detailed information about this medication, a checklist of the above conditions, detailed information on birth control options, and a consent form for your review and signature.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• change to hair texture
• difficulty in wearing contact lenses (may continue after treatment is stopped)
• dizziness
• dry eyes (may continue after treatment is stopped)
• dry or itchy skin (especially of lips and face)
• dry mouth or nose
• fatigue
• flushing
• headache (mild)
• heartburn
• increased sensitivity of skin to sunlight
• nausea
• nosebleeds
• pain or tenderness of eyes
• persistent noise in ears
• thinning of hair (may continue after treatment is stopped)
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• back pain
• bone or joint pain
• burning, redness, itching, or other signs of eye inflammation
• decreased night vision
• headache (severe or continuing)
• increased blood pressure
• increased cholesterol and triglycerides in the blood
• increased frequency of infections
• increased liver enzymes in the blood
• mood changes
• muscle pain or stiffness
• peeling skin
• scaling, redness, burning, pain, or other signs of inflammation of lips
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of decreased thyroid function (e.g., constipation, cold intolerance, weight gain, fatigue)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of inflammatory bowel disease (e.g., severe abdominal or stomach pain, severe diarrhea, nausea, vomiting, rectal bleeding)
• swelling of feet and lower legs
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of increased blood pressure in the brain (e.g., lasting headache, nausea, vomiting, changes in vision)
• signs of blood vessel inflammation (e.g., bruising, red patches of skin)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of vision changes (e.g., blurred vision, distorted vision, cloudy surface on the eye)
• thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

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

Bones and joints: 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 this medication.

Cholesterol: 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication, contact your doctor as soon as possible.

Diabetes: 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to check your blood glucose levels more often.

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

If you experience severe abdominal pain, rectal bleeding, or severe diarrhea, you should stop using this medication and contact your doctor.

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

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: 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.

Pancreatitis: Retinoids can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Skin care: 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 alitretinoin, avoid exfoliators, waxing, and dermabrasion.

Sun sensitivity: 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: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your thyroid function regularly with blood tests while you are taking this medication.

Vision: This medication 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 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 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: Alitretinoin causes severe birth defects in an extremely high percentage of infants born to people who take this medication even for a short period of time during pregnancy.

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

People who may become pregnant must not be given 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. 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 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 alitretinoin passes into breast milk. If you are breast-feeding and taking this medication, it may harm your baby. People who are taking this medication must not breast-feed.

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

Seniors: The use of alitretinoin by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between alitretinoin and any of the following:

• amiodarone
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• birth control pills (estrogens and progestins)
• cobicistat
• diltiazem
• dronedarone
• drospirenone
• gemfibrozil
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
• lenacapavir
• letermovir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• methotrexate
• mifepristone
• multivitamins/minerals (with vitamins A, D, E, or K; folate; or iron)
• nirmatrelvir and ritonavir
• progestin-only birth control
• protein kinase inhibitors (e.g., ceritinib, imatinib, tucatinib)
• St. John’s Wort
• tetracycline antibiotics (tetracycline, doxycycline, minocycline)
• verapamil
• 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 this medication. 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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Hanzema