Indications for: XYOSTED

Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.

Limitations of Use:

Not established in men with age-related hypogonadism or men aged <18yrs.

Adult Dosage:

Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Give as SC inj into abdomen. ≥18yrs: 75mg once weekly. Decrease by 25mg if total testosterone trough level ≥650ng/dL; or, increase by 25mg if <350ng/dL.

Children Dosage:

<18yrs: not established.

XYOSTED Contraindications:

Male breast or prostate cancer. Pregnancy. Hypogonadal conditions not associated with structural or genetic etiologies.

Boxed Warning:

Blood pressure increases.

XYOSTED Warnings/Precautions:

BP increases can occur and can increase the risk for major adverse cardiovascular (CV) events (eg, MI, stroke, death). Consider baseline cardiovascular risk and ensure BP is controlled prior to initiation. Monitor BP approx. 6 weeks after initiating and periodically thereafter for new onset hypertension or exacerbations; re-evaluate benefits/risks if CV risk factors or disease develops. Measure total testosterone trough levels after 6 weeks of dosing, then 6 weeks after dose adjustment, and periodically during treatment. Monitor hematocrit prior to initiation and every 3 months during therapy; if elevation occurs, withhold until acceptable level; permanently discontinue if elevated after restarting treatment. Increased risk of worsening of BPH; monitor. Evaluate for prostate cancer prior to and during therapy. Monitor for venous thromboembolism; discontinue if suspected. Testosterone and/or other anabolic androgenic steroid abuse. Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Pre-existing cardiac, renal, or hepatic disease (discontinue if edema occurs). Possible sleep apnea in patients with obesity or chronic lung diseases. Monitor lipid profile (esp. after starting therapy), serum calcium (in cancer patients at risk of hypercalcemia/hypercalciuria) periodically. Risk of depression or suicide. May suppress spermatogenesis. Elderly. Not for use in women.

XYOSTED Classification:


XYOSTED Interactions:

Additive effects with concomitant medications that increase BP. May alter insulin sensitivity or glycemic control; reduce dose of antidiabetic agents if needed. Monitor INR and PT with concomitant oral anticoagulants. Increased fluid retention with corticosteroids. May affect thyroid levels.

Adverse Reactions:

Hematocrit increased, hypertension, PSA increased, inj site bruising, headache; worsening BPH, prostate cancer, venous thromboembolism, edema, hepatic dysfunction, gynecomastia.

Generic Drug Availability:


How Supplied:

Single-dose autoinjectors—4