Description
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.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tretinoin in the elderly.
Breastfeeding
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.
Drug Interactions
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 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.
- Aminocaproic Acid
- Apalutamide
- Aprotinin
- Avacopan
- Boceprevir
- Carbamazepine
- Ceritinib
- Chlortetracycline
- Clarithromycin
- Cobicistat
- Demeclocycline
- Doxycycline
- Enzalutamide
- Eravacycline
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Ketoconazole
- Letermovir
- Lonafarnib
- Lumacaftor
- Lymecycline
- Meclocycline
- Methacycline
- Mifepristone
- Minocycline
- Mitotane
- Nefazodone
- Nelfinavir
- Omadacycline
- Oxytetracycline
- Paclitaxel
- Paclitaxel Protein-Bound
- Palovarotene
- Paritaprevir
- Phenytoin
- Posaconazole
- Ribociclib
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
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.
- For acute promyelocytic leukemia (APL):
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
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
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.
CON-XXXXXXXX
