Neotigason 25 mg

Contraindications

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What is the most important information I should know about Neotigason 25 mg?

Neotigason 25 mg can harm an unborn baby or cause birth defects. Do not use Neotigason 25 mg if you are pregnant or plan to become pregnant within 3 years after you stop taking Neotigason 25 mg. Before and during treatment, and for 3 years after treatment, you must have negative pregnancy tests at regular intervals to make sure you are not pregnant.

Do not donate blood while taking Neotigason 25 mg and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains Acitretin.

Women taking Neotigason 25 mg must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause Neotigason 25 mg to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Neotigason 25 mg is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking Neotigason 25 mg and for 2 months after you stop taking it.

Undesirable effects

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What are the possible side effects of Neotigason 25 mg?

Applies to Neotigason 25 mg: oral capsule

As well as its needed effects, Neotigason 25 mg (the active ingredient contained in Neotigason 25 mg) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking Neotigason 25 mg, check with your doctor immediately:

More common:

• Back pain
• bad, unusual, or unpleasant (after) taste
• bone or joint pain
• change in taste
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with moving or walking
• excessive muscle tone
• feeling of warmth
• headache (severe and continuing)
• hearing loss
• increased sensitivity to pain
• increased sensitivity to touch
• muscle stiffness
• muscle tension or tightness
• nausea or vomiting (severe and continuing)
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• sleeplessness
• stiff, painful muscles
• thinning of the skin with easy bruising
• tingling in the hands and feet
• tongue irritation
• trouble sleeping
• unable to sleep

• Acid or sour stomach
• blurred vision
• belching
• breast pain
• eye pain
• eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of the eyes to light, or watery eyes
• general feeling of discomfort or illness
• heartburn
• increased hair growth on the forehead, back, arms, and legs
• indigestion
• itching of the vagina or genital area
• loosening of the fingernails
• pain during sexual intercourse
• redness or soreness around the fingernails
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth or on the tongue

• Abdominal or stomach pain
• bleeding gums
• bleeding time increased
• chest pain
• coughing, hoarseness, trouble in speaking, or flu-like symptoms
• coughing up blood
• darkened urine
• diarrhea
• difficulty in breathing or swallowing
• double vision or other problems in seeing, including decreased night vision after sunset and before sunrise
• increased menstrual flow or vaginal bleeding
• itchy or painful ears
• light-colored stools
• nosebleeds
• pale or cold hands or feet
• paralysis
• prolonged bleeding from cuts
• red or dark brown urine
• shortness of breath
• skin problems, such as abnormal sensation of burning or stinging, cracking, redness, skin irritation or rash (including a rash that looks like psoriasis), infection, ulcers, unusual odor, or small red spots in the skin
• sore on the edge of the eyelid (stye)
• thick, white, curd-like vaginal discharge
• unpleasant breath odor
• unusual tiredness or weakness
• vaginal itching or irritation
• vomiting of blood
• yellowing of the skin or eyes

• Assault
• attack
• burning, numbness, tingling, or painful sensations
• chest pain or discomfort
• confusion
• difficulty with breathing
• difficulty with speaking
• doing things to injure oneself
• force
• inability to move the arms, legs, or facial muscles
• inability to speak
• pain in the chest, groin, or legs, especially calves
• pain or discomfort in the arms, jaw, back, or neck
• shortness of breath
• slow speech
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arms or legs
• sudden, unexplained shortness of breath
• sweating
• thoughts of killing oneself
• unsteadiness or awkwardness
• vision changes
• weakness in the arms, hands, legs, or feet

If any of the following symptoms of overdose occur while taking Neotigason 25 mg, get emergency help immediately:

Symptoms of overdose:

• Dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• sensation of spinning

Some Neotigason 25 mg side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Chapped, red, or swollen lips
• difficulty in wearing contact lenses
• dry or runny nose
• dryness of the eyes
• increased ability to sunburn
• increased amount of ear wax (unusual)
• irritation in the mouth or swollen gums
• itchy skin
• loss of hair (usually reversible)
• nosebleeds
• scaling and peeling of the eyelids, fingertips, palms, and soles of feet
• sticky skin
• unusual thirst

• Constipation
• diarrhea
• increased sweating

• Cracking fingernails or fingernails break easily
• muscular pain, tenderness, wasting, or weakness

Neotigason 25 mg price

Therapeutic indications

Neotigason 25 mg Capsules USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with their use, Neotigason 25 mg Capsules USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Neotigason 25 mg Capsules USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.

Neotigason 25 mg is used to treat severe skin disorders, such as psoriasis. It works by allowing normal growth and development of the skin. Neotigason 25 mg will continue to work after you stop taking it, but after a time, the skin condition returns and you may need to take it again.

Neotigason 25 mg must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Neotigason 25 mg must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for Neotigason 25 mg.

Neotigason 25 mg is available only with your doctor's prescription.

Name of the medicinal product

Qualitative and quantitative composition

An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of etretinate with the advantage of a much shorter half-life when compared with etretinate. [PubChem]

Special warnings and precautions for use

Use Neotigason 25 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Neotigason 25 mg comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Neotigason 25 mg refilled.
• Take the capsule(s) by mouth with a meal at about the same time each day, or as directed by your doctor.
• To use the foam, shake well before each use. Point the canister down and dispense a small amount onto the affected area as needed. Gently message the area until the foam disappears. Repeat as needed.
• Continue to use Neotigason 25 mg even if your condition does not improve right away. Your condition may become worse for a short time before it improves. It may take 2 to 3 months before you see the full benefits of Neotigason 25 mg.
• If you miss a dose of Neotigason 25 mg, you may take it later the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Neotigason 25 mg.

This medication is a retinoid used in the treatment of severe psoriasis and other skin disorders in adults.

Read the Medication Guide provided by your pharmacist before you start using Neotigason 25 mg and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Read and complete the Patient Agreement and Informed Consent document before taking this drug.

Take this medication by mouth exactly as prescribed, usually once a day with your main meal.

The dosage is based on your medical condition and response to therapy. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of side effects may increase.

It may take 2 to 3 months before the full benefit of this medication is seen.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Dosage (Posology) and method of administration

Initial dose: 25 to 50 mg orally once a day, administered as a single dose with main meal

Maintenance dose: 25 to 50 mg orally once a day, administered upon an individual patient's response to initial treatment

Comments: When used with phototherapy, the healthcare provider should decrease the phototherapy dose, dependent on the patient's individual response.

Use: Treatment of severe psoriasis in adults

Severe renal impairment: Contraindicated

Severe liver impairment: Contraindicated

US BOXED WARNINGS:

-Neotigason 25 mg must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Neotigason 25 mg also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Neotigason 25 mg is a metabolite of etretinate and major human fetal abnormalities have been reported with the administration of Neotigason 25 mg and etretinate. Potentially, any fetus exposed can be affected.

-Ethanol must not be ingested by female patients either during treatment with Neotigason 25 mg or for 2 months after cessation of therapy.

-Because of the teratogenicity of Neotigason 25 mg, a program called T.A.P.P., Take Action to Prevent Pregnancy, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with Neotigason 25 mg and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The T.A.P.P. program requirements are described below and program materials are available at http://www.tevagenerics.com/Neotigason 25 mg or may be requested by calling 1-855-850-2138 Important Information for Women of Childbearing Potential

-Neotigason 25 mg should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

-Females of reproductive potential must not be given a prescription for Neotigason 25 mg until pregnancy is excluded. Neotigason 25 mg is contraindicated in females of reproductive potential unless the patient meets ALL of the following conditions:

-Must have had 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mInternational Units(mIU)/mL before receiving the initial prescription for Neotigason 25 mg. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue therapy with Neotigason 25 mg. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of therapy with Neotigason 25 mg. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception [birth control] simultaneously).

-Must have a pregnancy test repeated every month during treatment with Neotigason 25 mg. The patient must have a negative result from a urine or serum pregnancy test before receiving a prescription for Neotigason 25 mg. To encourage compliance with this recommendation, a limited supply of the drug should be prescribed. For at least 3 years after discontinuing therapy with Neotigason 25 mg, a pregnancy test must be repeated every 3 months.

-Must have selected and have committed to use 2 effective forms of contraception (birth control) simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy or is clearly postmenopausal.

-Effective forms of contraception should be used for at least 1 month prior to initiation of therapy with Neotigason 25 mg, during therapy with Neotigason 25 mg, and for at least 3 years after discontinuing therapy with Neotigason 25 mg. An Neotigason 25 mg Referral Form is available so that patients can receive an initial free contraceptive counseling session and pregnancy testing

-Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and injectable/implantable/ insertable/topical hormonal birth control products. Secondary forms of contraception include latex condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide).

-It has been established that Neotigason 25 mg interferes with the contraceptive effect of microdosed progestin preparations. 1 Microdosed "minipill" progestin preparations are not recommended for use with Neotigason 25 mg. It is not known whether other progestational contraceptives, such as implants and injectables, are adequate methods of contraception during Neotigason 25 mg therapy.

-Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's wort.

-Must have signed a Patient Agreement/Informed Consent for Female Patients that contains warnings about the risk of potential birth defects if the fetus is exposed to Neotigason 25 mg, about contraceptive failure, about the fact that they must not ingest beverages or products containing ethanol while taking Neotigason 25 mg and for 2 months after Neotigason 25 mg treatment has been discontinued, and about preventing pregnancy while taking Neotigason 25 mg and for at least 3 years after discontinuing Neotigason 25 mg.

-If pregnancy does occur during therapy with Neotigason 25 mg or at any time for at least 3 years following discontinuation of Neotigason 25 mg, the prescriber and patient should discuss the possible effects on the pregnancy.

-Neotigason 25 mg, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping Neotigason 25 mg therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects.

-Severe birth defects have been reported where conception occurred during the time interval when the patient was being treated with Neotigason 25 mg and/or etretinate. In addition, severe birth defects have also been reported when conception occurred after the mother completed therapy.

-Females who have taken etretinate- must continue to follow the contraceptive recommendations for etrenitate. Etrenitate is no longer marketed in the U.S.; for information, call 1-888-838-2872.

-Patients should not donate blood during and for at least 3 years following the completion of therapy with Neotigason 25 mg because women of childbearing potential must not receive blood from patients being treated with Neotigason 25 mg.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Data not available

Administration advice:

-This drug should be administered with meals.

Storage requirements:

-Protect from light

-Exposure to high temperatures and humidity should be avoided after the bottle is opened.

General:

-A medication guide must be given to the patient each time Neotigason 25 mg is dispensed, as required by law.

Monitoring:

-Hepatic: Liver function (prior to and during therapy)

-Metabolic: Lipid levels (baseline and every 1 to 2 weeks)

-Neurologic: Signs and symptoms of pseudotumor cerebri

-Women of child-bearing potential: Pregnancy tests prior to starting therapy, during treatment, and every 1 to 3 months for 2 years after therapy discontinuation.

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Neotigason 25 mg?

Ethanol

Clinical evidence has shown that etretinate can be formed with concurrent ingestion of Neotigason 25 mg and ethanol.

In a trial of 7 healthy male volunteers, Neotigason 25 mg treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of Neotigason 25 mg on glucose tolerance. Careful supervision of diabetic patients under treatment with Neotigason 25 mg is recommended.

It has not been established if there is a pharmacokinetic interaction between Neotigason 25 mg and combined oral contraceptives. However, it has been established that Neotigason 25 mg interferes with the contraceptive effect of microdosed progestin “minipill” preparations. Microdosed “minipill” progestin preparations are not recommended for use with Neotigason 25 mg. It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during Neotigason 25 mg therapy.

An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with Neotigason 25 mg is also contraindicated.

If Neotigason 25 mg is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.

Since both Neotigason 25 mg and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated.

Concomitant administration of vitamin A and/or other oral retinoids with Neotigason 25 mg must be avoided because of the risk of hypervitaminosis A.

There appears to be no pharmacokinetic interaction between Neotigason 25 mg and cimetidine, digoxin, or glyburide. Investigations into the effect of Neotigason 25 mg on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.

Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, blood-sugar levels should be monitored very carefully.

In clinical trials, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33%, and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to Neotigason 25 mg has stabilized.

Elevations of AST (SGOT), ALT (SGPT), or LDH were experienced by approximately 1 in 3 patients treated with Neotigason 25 mg. It is recommended that these tests be performed prior to initiation of therapy with Neotigason 25 mg, at 1-to 2-week intervals until stable, and thereafter at intervals as clinically indicated.