Tlando Side Effects

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 2%): increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Polycythemia [see Warnings and Precautions ( 5.1 )] Venous Thromboembolism [see Warnings and Precautions ( 5.2 )] Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [see Warnings and Precautions ( 5.3 )] Blood Pressure Increases [see Warnings and Precautions ( 5.4 )] Hepatic Adverse Effects [see Warnings and Precautions ( 5.8 )] Edema [see Warnings and Precautions ( 5.9 )] Sleep Apnea [see Warnings and Precautions ( 5.10 )] Gynecomastia [see Warnings and Precautions ( 5.11 )] Lipid Changes [see Warnings and Precautions ( 5.12 )] Hypercalcemia [see Warnings and Precautions ( 5.13 )] Decreased Thyroxine-binding Globulin [see Warnings and Precautions ( 5.14 )] Increases in Prolactin [see Warnings and Precautions ( 5.15 )] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of TLANDO 225 mg twice daily, without dose titration, was evaluated in 233 hypogonadal males during two clinical studies: Study LPCN 1021-18-001 (18-001) and Study LPCN 1021-16-002 (16-002) [see Clinical Studies ( 14 )].

In Study 18-001, an uncontrolled ambulatory blood pressure monitoring (ABPM) study, 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately four months.

Patients had a median age of 54 years (range 26-75), 79% were White, 18% were Black, and 2% were Asian.

In 138 hypogonadal male patients, 70% (n=96) were obese (BMI≥30 kg/m 2 ), 24% (n=33) reported a history of type 2 diabetes, and 48% (n=66) reported a history of hypertension.

Table 1 summarizes adverse reactions ( > 2%) reported in patients receiving TLANDO in Study 18-

Adverse Reactions ≥ 2% in Patients Receiving TLANDO in Study 18-001 Adverse Reaction Overall (N=138) n (%) Hypertension 7 (5.1) Hematocrit increased 6 (4.3) Upper respiratory tract infection 5 (3.6) Four of the 138 patients (2.9%) in Study 18-001 reported adverse reactions that led to premature discontinuation from the study, including dizziness (n=1), weight increased (n=1), insomnia (n=1), and hypertension (n=2).

In Study 16-002, 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days.