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Targretin

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Targretin

Targretin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Targretin (bexarotene) is used to treat skin lesions of cutaneous T-cell lymphoma (CTCL) in patients who have not responded to or not tolerated other therapies. It is a retinoid (vitamin A derivative). Common side effects include headache, tiredness, nausea, vomiting, dry skin, diarrhea, or trouble sleeping.

The recommended initial dose of Targretin is 300 mg/m2/day, taken as a single oral daily dose with a meal. Vitamin A may increase side effects when taking Targretin. Limit vitamin A supplements to the recommended daily allowance (RDA) of 4000 to 5000 International Units (IU) a day. Check vitamin supplement labels for amounts of Vitamin A. Targretin may interact with gemfibrozil, ketoconazole, itraconazole, erythromycin, rifampin, phenobarbital, phenytoin, or diabetes medicine. Tell your doctor all medications and supplements you use. Targretin must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor. It is not known if this drug passes into breast milk. Due to possible harm to the nursing infant, breast-feeding while using this drug is not recommended.

Our Targretin (bexarotene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Targretin in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking bexarotene and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or
  • symptoms of pancreatitis (inflammation of the pancreas) such as persistent nausea, vomiting, and abdominal or back pain.

Other, less serious side effects may be more likely to occur. Continue to take bexarotene and talk to your doctor if you experience:

  • an increase in fats in the blood (blood lipids) such as cholesterol or triglycerides (blood tests will detect this);
  • a underactive thyroid (blood tests will detect this);
  • blood problems;
  • headache;
  • fatigue;
  • weakness or loss of strength;
  • swelling;
  • rash;
  • dry skin;
  • infections;
  • nausea; or
  • diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Targretin (Bexarotene) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Targretin Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, tiredness, nausea, vomiting, dry skin, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can frequently increase the level of "bad" fats (cholesterol/triglyceride) in your blood. Your doctor will order blood tests to measure these fats. If your blood fat levels get too high, your bexarotene dose may need to be lowered or stopped, or you may need to start cholesterol medication.

This medication can cause an underactive thyroid (hypothyroidism). Tell your doctor immediately if any of these symptoms of low thyroid occur: unusual weight gain, feeling cold, constipation, slow heartbeat, low on energy. Your doctor will order a blood test and may start you on thyroid medication.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach pain, swelling of the hands/feet, muscle pain/stiffness/cramps, fast/pounding heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe abdominal/back/stomach pain, persistent nausea/vomiting, dark urine, vision changes, yellowing eyes and skin.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice the following symptoms of an allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Targretin (Bexarotene)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Targretin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety of Targretin® (bexarotene) capsules has been evaluated in clinical studies of 152 patients with CTCL who received Targretin® (bexarotene) capsules for up to 97 weeks and in 352 patients in other studies. The mean duration of therapy for the 152 patients with CTCL was 166 days. The most common adverse events reported with an incidence of at least 10% in patients with CTCL treated at an initial dose of 300 mg/m2/day of Targretin® (bexarotene) capsules are shown in Table 1. The events at least possibly related to treatment are lipid abnormalities (elevated triglycerides, elevated total and LDL cholesterol and decreased HDL cholesterol), hypothyroidism, headache, asthenia, rash, leukopenia, anemia, nausea, infection, peripheral edema, abdominal pain, and dry skin. Most adverse events occurred at a higher incidence in patients treated at starting doses of greater than 300 mg/m2/day (see Table 1).

Adverse events leading to dose reduction or study drug discontinuation in at least two patients were hyperlipemia, neutropenia/leukopenia, diarrhea, fatigue/lethargy, hypothyroidism, headache, liver function test abnormalities, rash, pancreatitis, nausea, anemia, allergic reaction, muscle spasm, pneumonia, and confusion.

The moderately severe (NCI Grade 3) and severe (NCI Grade 4) adverse events reported in two or more patients with CTCL treated at an initial dose of 300 mg/m2/day of Targretin® (bexarotene) capsules (see Table 2) were hypertriglyceridemia, pruritus, headache, peripheral edema, leukopenia, rash, and hypercholesteremia. Most of these moderately severe or severe adverse events occurred at a higher rate in patients treated at starting doses of greater than 300 mg/m2/day than in patients treated at a starting dose of 300 mg/m2/day.

As shown in Table 3, in patients with CTCL receiving an initial dose of 300 mg/m2/day, the incidence of NCI Grade 3 or 4 elevations in triglycerides and total cholesterol was 28% and 25%, respectively. In contrast, in patients with CTCL receiving greater than 300 mg/m2/day, the incidence of NCI Grade 3 or 4 elevated triglycerides and total cholesterol was 45% and 45%, respectively. Other Grade 3 and 4 laboratory abnormalities are shown in Table 3.

In addition to the 152 patients enrolled in the two CTCL studies, 352 patients received Targretin® (bexarotene) capsules as monotherapy for various advanced malignancies at doses from 5 mg/m2/day to 1000 mg/m2/day. The common adverse events (incidence greater than 10%) were similar to those seen in CTCL.

In the 504 patients (CTCL and non-CTCL) who received Targretin® (bexarotene) capsules as monotherapy, drug-related serious adverse events that were fatal in one patient each, were acute pancreatitis, subdural hematoma, and liver failure.

In the patients with CTCL receiving an initial dose of 300 mg/m2/day of Targretin® (bexarotene) capsules, adverse events reported at an incidence of less than 10%, and not included in Tables 1-3 or discussed in other parts of labeling and possibly related to treatment were as follows:

Body as a Whole: chills, cellulitis, chest pain, sepsis, and monilia.

Cardiovascular: hemorrhage, hypertension, angina pectoris, right heart failure, syncope, and tachycardia.

Digestive: constipation, dry mouth, flatulence, colitis, dyspepsia, cheilitis, gastroenteritis, gingivitis, liver failure, and melena.

Hematic and Lymphatic: eosinophilia, thrombocythemia, coagulation time increased, lymphocytosis, and thrombocytopenia.

Metabolic and Nutritional: LDH increased, creatinine increased, hypoproteinemia, hyperglycemia, weight decreased, weight increased, and amylase increased.

Musculoskeletal: arthralgia, myalgia, bone pain, myasthenia, and arthrosis.

Nervous: depression, agitation, ataxia, cerebrovascular accident, confusion, dizziness, hyperesthesia, hypesthesia, and neuropathy.

Respiratory: pharyngitis, rhinitis, dyspnea, pleural effusion, bronchitis, cough increased, lung edema, hemoptysis, and hypoxia.

Skin and Appendages: skin ulcer, acne, alopecia, skin nodule, macular papular rash, pustular rash, serous drainage, and vesicular bullous rash.

Special Senses: dry eyes, conjunctivitis, ear pain, blepharitis, corneal lesion, keratitis, otitis externa, and visual field defect.

Urogenital: albuminuria, hematuria, urinary incontinence, urinary tract infection, urinary urgency, dysuria, kidney function abnormal, and breast pain.

Table 1. Adverse Events with Incidence ≥ 10% in CTCL Trials

Body System
  Adverse Event1,2
Initial Assigned Dose Group (mg/m2/day)
300 >300
N=84
N(%)
N=53
N(%)
METABOLIC AND NUTRITIONAL DISORDERS
  Hyperlipemia 66(78.6) 42(79.2)
  Hypercholesteremia 27(32.1) 33(62.3)
  Lactic dehydrogenase increased 6(7.1) 7(13.2)
BODY AS A WHOLE
  Headache 25(29.8) 22(41.5)
  Asthenia 17(20.2) 24(45.3)
  Infection 11(13.1) 12(22.6)
  Abdominal pain 9(10.7) 2(3.8)
  Chills 8(9.5) 7(13.2)
  Fever 4(4.8) 9(17.0)
  Flu syndrome 3(3.6) 7(13.2)
  Back pain 2(2.4) 6(11.3)
  Infection bacterial 1(1.2) 7(13.2)
ENDOCRINE
  Hypothyroidism 24(28.6) 28(52.8)
SKIN AND APPENDAGES
  Rash 14(16.7) 12(22.6)
  Dry skin 9(10.7) 5(9.4)
  Exfoliative dermatitis 8(9.5) 15(28.3)
  Alopecia 3(3.6) 6(11.3)
HEMIC AND LYMPHATIC SYSTEM
  Leukopenia 14(16.7) 25(47.2)
  Anemia 5(6.0) 13(24.5)
  Hypochromic anemia 3(3.6) 7(13.2)
DIGESTIVE SYSTEM
  Nausea 13(15.5) 4(7.5)
  Diarrhea 6(7.1) 22(41.5)
  Vomiting 3(3.6) 7(13.2)
  Anorexia 2(2.4) 12(22.6)
CARDIOVASCULAR SYSTEM
  Peripheral edema 11(13.1) 6(11.3)
NERVOUS SYSTEM
  Insomnia 4(4.8) 6(11.3)
1Preferred English term coded according to Ligand-modified COSTART 5 Dictionary.
2Patients are counted at most once in each AE category.

Table 2. Incidence of Moderately Severe and Severe Adverse Events Reported in at Least Two Patients (CTCL Trials)

Body System
  Adverse Event1,2
Initial Assigned Dose Group (mg/m2/day)
300 (N=84) >300 (N=53)
Mod Sev Severe Mod Sev Severe
N(%) N(%) N(%) N(%)
BODY AS A WHOLE
  Asthenia 1(1.2) 0(0.0) 11(20.8) 0(0.0)
  Headache 3(3.6) 0(0.0) 5(9.4) 1(1.9)
  Infection bacterial 1(1.2) 0(0.0) 0(0.0) 2(3.8)
CARDIOVASCULAR SYSTEM
  Peripheral edema 2(2.4) 1(1.2) 0(0.0) 0(0.0)
DIGESTIVE SYSTEM
  Anorexia 0(0.0) 0(0.0) 3(5.7) 0(0.0)
  Diarrhea 1(1.2) 1(1.2) 2(3.8) 1(1.9)
  Pancreatitis 1(1.2) 0(0.0) 3(5.7) 0(0.0)
  Vomiting 0(0.0) 0(0.0) 2(3.8) 0(0.0)
ENDOCRINE
  Hypothyroidism 1(1.2) 1(1.2) 2(3.8) 0(0.0)
HEM. & LYMPH. SYS.
  Leukopenia 3(3.6) 0(0.0) 6(11.3) 1(1.9)
META. AND NUTR. DIS.
  Bilirubinemia 0(0.0) 1(1.2) 2(3.8) 0(0.0)
  Hypercholesteremia 2(2.4) 0(0.0) 5(9.4) 0(0.0)
  Hyperlipemia 16(19.0) 6(7.1) 17(32.1) 5(9.4)
  SGOT/AST increased 0(0.0) 0(0.0) 2(3.8) 0(0.0)
  SGPT/ALT increased 0(0.0) 0(0.0) 2(3.8) 0(0.0)
RESPIRATORY SYSTEM
  Pneumonia 0(0.0) 0(0.0) 2(3.8) 2(3.8)
SKIN AND APPENDAGES
  Exfoliative dermatitis 0(0.0) 1(1.2) 3(5.7) 1(1.9)
  Rash 1(1.2) 2(2.4) 1(1.9) 0(0.0)
1Preferred English term coded according to Ligand-modified COSTART 5 Dictionary.
2Patients are counted at most once in each A Ecategory. Patients are classified by the highest severity within each row.

Table 3. Treatment-Emergent Abnormal Laboratory Values in CTCL Trials

Analyte Initial Assigned Dose (mg/m2/day)
300 >300
N=831 N=531
Grade 32 Grade 42 Grade 3 Grade 4
(%) (%) (%) (%)
Triglycerides3 21.3 6.7 31.8 13.6
Total Cholesterol3 18.7 6.7 15.9 29.5
Alkaline Phosphatase 1.2 0.0 0.0 1.9
Hyperglycemia 1.2 0.0 5.7 0.0
Hypocalcemia 1.2 0.0 0.0 0.0
Hyponatremia 1.2 0.0 9.4 0.0
SGPT/ALT 1.2 0.0 1.9 1.9
Hyperkalemia 0.0 0.0 1.9 0.0
Hypernatremia 0.0 1.2 0.0 0.0
SGOT/AST 0.0 0.0 1.9 1.9
Total Bilirubin 0.0 0.0 0.0 1.9
ANC 12.0 3.6 18.9 7.5
ALC 7.2 0.0 15.1 0.0
WBC 3.6 0.0 11.3 0.0
Hemoglobin 0.0 0.0 1.9 0.0
1Number of patients with at least one analyte value post-baseline.
2Adapted from NCI Common Toxicity Criteria, Grade 3 and 4, Version 2.0. Patients are considered to have had a Grade 3 or 4 value if either of the following occurred: a) Value becomes Grade 3 or 4 during the study; b) Value is abnormal at baseline and worsens to Grade 3 or 4 on study, including all values beyond study drug discontinuation, as defined in data handling conventions.
3The denominator used to calculate the incidence rates for fasting Total Cholesterol and Triglycerides were N=75 for the 300 mg/m 2/day initial dose group and N=44 for the >300 mg/m2/day initial dose group.

Read the entire FDA prescribing information for Targretin (Bexarotene) »

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Targretin - User Reviews

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