Natesto Nasal Gel

NATESTO NASAL GEL- testosterone gel, metered
Trimel Pharmaceuticals Corporation

1. INDICATIONS AND USAGE

Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of use:

  • Safety and efficacy of Natesto in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].

2. DOSAGE AND ADMINISTRATION

2.1. Dosing

The recommended dose of Natesto is 11 mg of testosterone (2 pump actuations; 1 actuation per nostril) administered intranasally three times daily for a total daily dose of 33 mg.

Serum total testosterone concentrations should be checked periodically, starting as soon as one month after initiating treatment with Natesto. When the total testosterone concentration consistently exceeds 1050 ng/dL, therapy with Natesto should be discontinued. If the total testosterone concentration is consistently below 300 ng/dL, an alternative treatment should be considered.

2.2. Administration Instructions

Natesto is administered intranasally three times daily once in the morning, once in the afternoon and once in the evening (6 to 8 hours apart), preferably at the same time each day. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose. Do not administer Natesto to other parts of the body.

Preparing the Pump

When using Natesto for the first time, patients should be instructed to prime the pump by inverting the pump, depressing the pump 10 times, and discarding any small amount of product dispensed directly into a sink and then washing the gel away thoroughly with warm water. The tip should be wiped with a clean, dry tissue. If the patient gets Natesto gel on their hands, it is recommended that they wash their hands with warm water and soap. This priming should be done only prior to the first use of each dispenser.

Administering the Dose

To administer the dose, patients should be instructed to perform the following steps:

  • Blow the nose.
  • Remove the cap from the dispenser.
  • Place the right index finger on the pump of the actuator and while in front of a mirror, slowly advance the tip of the actuator into the left nostril upwards until their finger on the pump reaches the base of the nose. Administering the Dose
  • Tilt the actuator so that the opening on the tip of the actuator is in contact with the lateral wall of the nostril to ensure that the gel is applied to the nasal wall.Tilt the Actuator
  • Slowly depress the pump until it stops.
  • Remove the actuator from the nose while wiping the tip along the inside of the lateral nostril wall to fully transfer the gel.
  • Using your left index finger, repeat the steps outlined in bullets 3 through 6 for the right nostril.
  • Use a clean, dry tissue to wipe the tip of the actuator.
  • Replace the cap on the dispenser.
  • Press on the nostrils at a point just below the bridge of the nose and lightly massage.
  • Refrain from blowing the nose or sniffing for 1 hour after administration.

The dispenser should be replaced when the top of the piston inside the dispenser reaches the arrow at the top of the inside label. The inside label may be found by unwrapping the outer flap from around the container.

DispenserAdministering the DoseTilt the ActuatorDispenser

2.3. Use with Nasally Administered Drugs Other Than Sympathomimetic Decongestants

The drug interaction potential between Natesto and nasally administered drugs other than sympathomimetic decongestants is unknown. Therefore, Natesto is not recommended for use with nasally administered drugs other than sympathomimetic decongestants (e.g., oxymetazoline) [see Drug Interactions (7.4) and Clinical Pharmacology (12.3)].

2.4. Temporary Discontinuation of Use for Severe Rhinitis

If the patient experiences an episode of severe rhinitis, temporarily discontinue Natesto therapy pending resolution of the severe rhinitis symptoms. If the severe rhinitis symptoms persist, an alternative testosterone replacement therapy is recommended.

3. DOSAGE FORMS AND STRENGTHS

Natesto is a slightly yellow gel for intranasal use and is available in a dispenser with a metered dose pump. One pump actuation delivers 5.5 mg of testosterone.

4. CONTRAINDICATIONS

Natesto is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precaution (5.3)].

Natesto is contraindicated in women who are or who may become pregnant, or who are breast-feeding. Natesto may cause fetal harm when administered to a pregnant woman. Natesto may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. If a pregnant woman is exposed to Natesto, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1, 8.3)].

5. WARNINGS AND PRECAUTIONS

5.1. Nasal Adverse Reactions and Limited Long-Term Information on Nasal Safety

Nasal adverse reactions, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort and nasal scabbing, were reported in the clinical trial experience with Natesto. All nasal adverse reactions except one (a single case of upper respiratory infection) were reported as mild or moderate in severity; however, long-term clinical trial data on nasal safety is available in a limited number of subjects [see Adverse Reactions (6.2)]. Patients should be instructed to report any nasal symptoms or signs to their health care professional. In that circumstance, health care professionals should determine whether further evaluation (e.g., otorhinolaryngology consultation) or discontinuation of Natesto is appropriate.

5.2. Use in Patients with Chronic Nasal Conditions and Alterations in Nasal Anatomy

Due to lack of clinical data on the safety or efficacy, Natesto is not recommended for use in the following patients:

  • History of nasal disorders;
  • History of nasal or sinus surgery;
  • History of nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum;
  • Mucosal inflammatory disorders (e.g, Sjogren’s syndrome); and
  • Sinus disease.

5.3. Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer

  • Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
  • Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It would be appropriate to re-evaluate patients 3 to 6 months after initiation of treatment and then in accordance with prostate cancer screening practices [see Contraindications (4)].

5.4. Polycythemia

Increases in hematocrit, reflective of increases in red blood cell mass, may require discontinuation of Natesto . Check hematocrit prior to initiating testosterone treatment. It would be appropriate to re-evaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.

5.5. Venous Thromboembolism

There have been postmarketing reports of venous thromboembolic events , including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as Natesto. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for (DVT) and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Natesto and initiate appropriate workup and management [see Adverse Reactions (6.2)].

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