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Vantas

Last reviewed on RxList: 2/22/2019
Vantas Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/22/2019

Vantas (histrelin acetate) Subcutaneous Implant is a synthetic form of gonadotropin releasing hormone (GnRH) used to treat symptoms of prostate cancer in men. Vantas should not be used in women or children. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself. Common side effects of Vantas include:

  • irritation at the implant site (bruising, pain, redness)
  • mood swings
  • headache
  • hot flashes (flushing)
  • increased sweating
  • night sweats
  • tiredness
  • swelling of the ankles/feet
  • constipation
  • shrinking of the testicles
  • pain or swelling of the testicles
  • reduced sexual interest
  • impotence
  • difficult having an orgasm
  • nosebleeds
  • weight gain or loss
  • feeling hot or cold
Infrequently, breast tenderness or swelling may occur in men and boys as a result of lowered testosterone levels.

The recommended dose of Vantas is one implant for 12 months. Each implant contains 50 mg histrelin acetate to deliver 41 mg histrelin. Vantas may interact with other drugs. Tell your doctor all medications and supplements you use. Vantas is not intended for use in women and must not be used during pregnancy or while breastfeeding; consult your doctor.

Our Vantas (histrelin acetate) Subcutaneous Implant 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.

Vantas Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • bone pain, numbness or weakness in your legs or feet;
  • painful or difficult urination, blood in your urine;
  • a seizure; or
  • mental problems--crying spells, anger, aggression, feeling restless or irritable.

Common side effects may include:

  • hot flashes;
  • urination problems;
  • constipation;
  • breast swelling or tenderness (in males or females);
  • feeling tired;
  • decreased testicle size, trouble getting an erection; or
  • redness, bruising, or skin irritation where the implant was inserted.

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.

Read the entire detailed patient monograph for Vantas (Histrelin Acetate)

Vantas Professional Information

SIDE EFFECTS

Adverse Reactions In Clinical Trials

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 VANTAS was evaluated in 171 patients with prostate cancer treated for up to 36 months in two clinical trials. The pivotal study (Study 1) consisted of 138 patients, while a separate supportive study (Study 2) consisted of 33 patients.

VANTAS, like other GnRH analogs, caused a transient increase in serum testosterone concentrations during the first week of treatment. Therefore, potential exacerbations of signs and symptoms of the disease during the first few weeks of treatment are of concern in patients with vertebral metastases and/or urinary obstruction or hematuria. If these conditions are aggravated, it may lead to neurological problems such as weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms [see WARNINGS AND PRECAUTIONS].

In the first 12 months after initial insertion of the implant(s), an implant extruded through the incision site in eight of 171 patients in the clinical trials (see the Recommended Procedure for correct implant placement).

In the pivotal study (Study 1) a detailed evaluation for implant site reactions was conducted. Out of the 138 patients in the study, 19 patients (13.8%) experienced local or insertion site reactions. All these local site reactions were reported as mild in severity. The majority were associated with initial insertion or removal and insertion of a new implant, and began and resolved within the first two weeks following implant insertion. Reactions persisted in 4 (2.8%) patients. An additional 4 (2.8%) patients developed application-site reactions after the first two weeks following insertion.

Local reactions after implant insertion included bruising (7.2% of patients) and pain/soreness/tenderness (3.6% of patients). Other, less frequently reported, reactions included erythema (2.8% of patients) and swelling (0.7% of patients). In this study, two patients had events described as local infections/inflammations, one that resolved after treatment with oral antibiotics and the other without treatment.

Local reactions following insertion of a subsequent implant were comparable to those seen after initial insertion.

The following possibly or probably related systemic adverse events occurred during clinical trials of up to 24 months of treatment with VANTAS, and were reported in ≥ 2% of patients (Table 1).

Table 1: Incidence (%) of Possibly or Probably Related Systemic Adverse Events Reported by ≥ 2% of Patients Treated with VANTAS for up to 24 Months

Body System Adverse Event Number (%)
Vascular Disorders Hot flashes* 112 (65.5%)
General Disorders Fatigue 17 (9.9%)
Weight increased 4 (2.3%)
Skin and Appendage Disorders Implant site reaction 10 (5.8%)
Reproductive System and Breast Disorders Erectile dysfunction' 6 (3.5%)
Gynecomastia* 7 (4.1%)
Testicular atrophy* 9 (5.3%)
Psychiatric Disorders Insomnia 5 (2.9%)
Libido decreased* 4 (2.3%)
Renal and Urinary Disorders Renal impairment** 8 (4.7%)
Gastrointestinal Disorders Constipation 6 (3.5%)
Nervous System Disorders Headache 5 (2.9%)
* Expected pharmacological consequences of testosterone suppression.
** 5 of the 8 patients had a single occurrence of mild renal impairment (defined as creatinine clearance ≥ 30 < 60 mL/min), which returned to a normal range by the next visit.

Hot flashes were the most common adverse event reported (65.5% of patients). In terms of severity, 2.3% of patients reported severe hot flashes, 25.4% of patients reported moderate hot flashes and 37.7% reported mild hot flashes. In addition, the following possibly or probably related systemic adverse events were reported by < 2% of patients using VANTAS in clinical studies.

  • Blood and Lymphatic System Disorders: Anemia
  • Cardiac Disorders: Palpitations, ventricular extrasystoles
  • Gastrointestinal Disorders: Abdominal discomfort, nausea
  • General Disorders: Feeling cold, lethargy, malaise, edema peripheral, pain, pain exacerbated, weakness, weight decreased
  • Hepatobiliary Disorders: Hepatic disorder
  • Injury, Poisoning and Procedural Complications: Stent occlusion
  • Laboratory Investigations: Aspartate aminotransferase increased, blood glucose increased, blood lactate dehydrogenase increased, blood testosterone increased, creatinine clearance decreased, prostatic acid phosphatase increased
  • Metabolism and Nutrition Disorders: Appetite increased, fluid retention, food craving, hypercalcaemia, hypercholesterolemia
  • Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, back pain aggravated, bone pain, muscle twitching, myalgia, neck pain, pain in limb
  • Nervous System Disorders: Dizziness, tremor
  • Psychiatric Disorders: Depression, irritability
  • Renal and Urinary Disorders: Calculus renal, dysuria, hematuria aggravated, renal failure aggravated, urinary frequency, urinary frequency aggravated, urinary retention
  • Reproductive System and Breast Disorders: Breast pain, breast tenderness, genital pruritus male, gynecomastia aggravated, sexual dysfunction
  • Respiratory, Thoracic and Mediastinal Disorders: Dyspnea exertional
  • Skin and Subcutaneous Tissue Disorders: Contusion, hypotrichosis, night sweats, pruritus, sweating increased
  • Vascular Disorders: Flushing, hematoma
  • Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist analog. It can be anticipated that long periods of medical castration in men will have effects on bone density.

Post-marketing

The following adverse reactions have been identified during post approval use of VANTAS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Pituitary Apoplexy

Cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of pituitary apoplexy cases occurring within 2 weeks of the final dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, opthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Drug-Induced Liver Injury

Severe liver injury has been reported in association with VANTAS. The toxicity was reversible with the removal of the VANTAS implant.

Nervous System Disorders

Convulsions

Read the entire FDA prescribing information for Vantas (Histrelin Acetate)

Related Resources for Vantas

Read the Vantas User Reviews »

© Vantas Patient Information is supplied by Cerner Multum, Inc. and Vantas Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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