atic disease.
• Sleep apnea may occur in those with risk factors.
• Monitor prostate specific antigen (PSA) and lipid concentrationsperiodically.
• Depression and suicidal ideation have occurred during clinical trials inpatients treated with JATENZO.
ADVERSE REACTIONS
Most common adverse reactions (incidence > 2%): polycythemia, diarrhea,dyspepsia, eructation, peripheral edema, nausea, increased hematocrit,headache, prostatomegaly, and hypertension.
To report SUSPECTED ADVERSE REACTIONS, contact ClarusTherapeutics, Inc. at 1-800-208-4115 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
• Androgens may decrease blood glucose and therefore may decrease insulinrequirements in diabetic patients.
• Changes in anticoagulant activity may be seen with androgens. Morefrequent monitoring of International Normalized Ratio (INR) andprothrombin time is recommended in patients taking warfarin.
• Use of testosterone with corticosteroids may result in increased fluidretention. Use with caution, particularly in patients with cardiac, renal, orhepatic disease.
• Concomitant administration of medications that are known to increaseblood pressure may lead to additional increases in blood pressure whenused with JATENZO.
USE IN SPECIFIC POPULATIONS
• Geriatric Patients: There are insufficient long-term safety data to assess thepotential risks of cardiovascular disease and prostate cancer.
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide
Revised: 03/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: BLOOD PRESSURE INCREASES
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Confirmation of Hypogonadism Before Initiation of JATENZO
2.2 Dosing and Dose Adjustment Information
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 Increase in Blood Pressure
5.2 Polycythemia
5.3 Cardiovascular Risk
5.4 Worsening of Benign Prostatic Hyperplasia (BPH) and PotentialRisk of Prostate Cancer
5.5 Venous Thromboembolism
5.6 Abuse of Testosterone and Monitoring of TestosteroneConcentrations
5.7 Not for Use in Women
5.8 Potential for Adverse Effects on Spermatogenesis
5.9 Hepatic Adverse Events
5.10 Edema
5.11 Gynecomastia
5.12 Sleep Apnea
5.13 Lipids
5.14 Hypercalcemia
5.15 Decreased Thyroxine-binding Globulin
5.16 Risk of Depression and Suicide
6. ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7. DRUG INTERACTIONS
7.1 Insulin
7.2 Oral Vitamin K Antagonist Anticoagulants
7.3 Corticosteroids
7.4 Medications that May Also Increase Blood Pressure
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
9. DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Clinical Trials in Hypogonad |
