Pronunciation:

TRET-i-noin

Brand Names:

• Vesanoid

Dosage Forms:

• Capsule, Liquid Filled

Warnings:

Tretinoin can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin and for 1 week after the last dose.Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin for moderate and severe Differentiation Syndrome until resolution.

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

Retinoid

Uses of This Medicine:

Tretinoin is used to treat acute promyelocytic leukemia (APL) in patients whose cancer has come back or did not respond to anthracycline chemotherapy or in patients who are unable to receive anthracycline-based chemotherapy.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tretinoin in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tretinoin in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Aminocaproic Acid
• Apalutamide
• Aprotinin
• Avacopan
• Boceprevir
• Carbamazepine
• Ceritinib
• Chlortetracycline
• Cholera Vaccine
• Clarithromycin
• Cobicistat
• Demeclocycline
• Doxycycline
• Ebola Zaire Vaccine, Live
• Enzalutamide
• Eravacycline
• Fosphenytoin
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ivosidenib
• Ketoconazole
• Letermovir
• Lonafarnib
• Lumacaftor
• Lymecycline
• Meclocycline
• Methacycline
• Mifepristone
• Minocycline
• Mitotane
• Nefazodone
• Nelfinavir
• Omadacycline
• Oxytetracycline
• Palovarotene
• Paritaprevir
• Phenytoin
• Posaconazole
• Ribociclib
• Rifampin
• Rifapentine
• Ritonavir
• Rolitetracycline
• Rotavirus Vaccine, Live
• Saquinavir
• Sarecycline
• St John's Wort
• Tazemetostat
• Telaprevir
• Telithromycin
• Tetracycline
• Tigecycline
• Tranexamic Acid
• Troleandomycin
• Tucatinib
• Vitamin A
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluconazole
• Mavacamten

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Intracranial hypertension (increased pressure in the head) or
• Kidney disease or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with food. Swallow the capsule whole with water. Do not chew, dissolve, or open it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For acute promyelocytic leukemia (APL):
    • Adults and children 1 year of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 22.5 milligrams per square meter (mg/m[2]) of BSA taken 2 times a day.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 10 hours until your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 10 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time.

If you vomit after taking a dose, take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, you must have a negative pregnancy test 1 week before starting this medicine. Use 2 forms of effective birth control to keep from getting pregnant during treatment and for 1 month after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 1 week after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. Check with your doctor right away if you start to have chest discomfort, pain, or tightness, cough, fever, swelling in the hands, ankles, or feet, trouble breathing, unusual tiredness or weakness, or weight gain.

This medicine may cause leukocytosis (high white blood cell count), which may be life-threatening. It may also increase cholesterol and triglycerides (fats) in the blood. Talk with your doctor if you have any concerns about this.

This medicine may increase pressure in the head, especially in children, which may lead to vision loss or serious brain problems. Check with your doctor right away if you or your child has a bad headache, blurred vision, dizziness, nausea, vomiting, or seizures.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious blood clots, including stroke or heart attack. Check with you doctor right away if you have back or side pain, blurred vision, chest pain or discomfort, inability to speak, nausea, pain or discomfort in the arms, jaw, back ,or neck, seizures, severe or sudden headache, slurred speech, sweating, temporary blindness, or weakness in the arm or leg on one side of the body, sudden and severe, or vomiting.

This medicine may cause some people to become dizzy or have severe headache. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous.

Some males who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

bleeding gums

bloating or swelling of face, arms, hands, lower legs, or feet

blue lips and fingernails

bluish color

blurred vision

bone pain

bruising

burning while urinating

change in ability to see colors, especially blue or yellow

changes in skin color

chest pain or tightness

confusion

coughing up blood

decreased amount of urine

dilated neck veins

discouragement

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

eye pain

fear, nervousness

feeling of warmth

feeling sad or empty

fever or chills

headache

increased menstrual flow or vaginal bleeding

increased blood pressure

increased sweating

increased thirst

irritability

itching, pain, redness, swelling, tenderness, or warmth on the skin

lack of appetite

loss of interest or pleasure

lower back or side pain

nausea

nosebleeds

painful or difficult urination

pale skin

paralysis

persistent bleeding or oozing from puncture sites, mouth, or nose

pounding in the ears

prolonged bleeding from cuts

rapid weight gain

red or black, tarry stools

red or dark brown urine

redness of the face, neck, arms and occasionally, upper chest

seeing, hearing, or feeling things that are not there

slow or fast heartbeat

sneezing

sore throat

sweating

swelling of the face, fingers, or lower legs

swelling of the foot or leg

tenderness

tingling of the hands or feet

trouble breathing

trouble concentrating

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

vomiting

vomiting of blood or material that looks like coffee grounds

Less common

Back pain

change in walking and balance

changes in patterns and rhythms of speech

clumsiness or unsteadiness

coma

dark urine

drowsiness

inability to move legs or arms

mood or mental changes

no blood pressure or pulse

pain or discomfort in arms, jaw, back, or neck

poor insight and judgement

problems with memory or speech

seizures

shakiness in the legs, arms, hands, or feet

slurred speech

stopping of the heart

stiff neck

trembling or shaking of the hands or feet

trouble in speaking

trouble recognizing objects

trouble thinking and planning

unconsciousness

upper right abdominal or stomach pain

yellow eyes and skin

Incidence not known

Bloating

constipation

dry mouth

indigestion

metallic taste

muscle weakness

pains in stomach, side, or abdomen, possibly radiating to the back

prominent superficial veins over affected area

skin tenderness, pain, swelling, warmth, discoloration

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

cracked lips

difficulty in moving

double vision

earache

halos around lights

hearing loss

heartburn

indigestion

joint pain

loss or thinning of the hair

muscle aches, cramps, pains, or stiffness

night blindness

overbright appearance of lights

stomach discomfort or upset

tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.