Vantas Side Effects

Please note - some side effects for Vantas may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vantas - for the Consumer

Vantas Implant

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vantas Implant:

Change in breast size; constipation; decreased sexual desire or ability; headache; hot flashes; sleeplessness; mild bruising, soreness, pain, tenderness, redness, or swelling at the insertion site; testicles become smaller; tiredness or weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Vantas Implant:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; blood in the urine; bone pain; breast pain; burning, numbness, or tingling; decreased amount of urine produced; fainting; fast or irregular heartbeat; paralysis; severe or persistent bleeding, redness, or pain at the insertion site; shortness of breath; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased hunger, thirst, or urination); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, unusual stomach pain, yellowing of the skin or eyes); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); trouble urinating or inability to urinate; unusual tiredness or weakness; weakness or loss of feeling in the legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Vantas Side Effects - for the Professional

Vantas

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].

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.

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

* 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.
Body System	Adverse Event	Number (%)
Vascular Disorders	Hot flashes*	112 (65.5%)
General Disorders	Fatigue Weight increased	17 (9.9%) 4 (2.3%)
Skin and Appendage Disorders	Implant Site Reaction	10 (5.8%)
Reproductive System and Breast Disorders	Erectile Dysfunction* Gynecomastia* Testicular atrophy*	6 (3.5%) 7 (4.1%) 9 (5.3%)
Psychiatric Disorders	Insomnia Libido decreased*	5 (2.9%) 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%)

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 an LH-RH 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.

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Side Effects by Body System - for Healthcare Professionals

Genitourinary

Genitourinary side effects in pediatric patients have included breast tenderness, dysmenorrhea, gynecomastia, and, menorrhagia. Genitourinary side effects in cancer patients have included erectile dysfunction, gynecomastia, testicular atrophy, breast pain, breast tenderness, male genital pruritus, aggravated gynecomastia, and sexual dysfunction.

Local

Local side effects in pediatric patients have included implant site reaction, keloid scars, scars, suture related complications, application site pain, wound infection, erythema, and post procedural pain. Local side effects in cancer patients have included implant site reaction, bruising, pain/soreness/tenderness, erythema, and swelling.

Nervous system

Nervous system side effects in pediatric patients have included headache, migraine, and mood swings. Nervous system side effects in cancer patients have included headache, dizziness, and tremor.

General

General side effects in pediatric patients have included feeling cold, benign pituitary tumor, increased weight, disease progression and influenza-like illness. General side effects in cancer patients have included feeling cold, lethargy, malaise, edema peripheral, pain, pain exacerbated, weakness, and weight decreased.

Dermatologic

Dermatologic side effects in pediatric patients have included pruritus. Dermatologic side effects in cancer patients have included contusion, hypotrichosis, night sweats, pruritus, and increased sweating.

Musculoskeletal

Musculoskeletal side effects in cancer patients have included arthralgia, back pain, back pain aggravated,
bone pain, muscle twitching, myalgia, neck pain, and pain in limbs.

Cardiovascular

Cardiovascular side effects in cancer patients have included palpitations, ventricular extrasystoles, stent occlusion, hematoma, and hot flashes.

Gastrointestinal

Gastrointestinal side effects in cancer patients have included abdominal discomfort, nausea, and constipation.

Hematologic

Hematologic side effects in cancer patients have included anemia.

Hepatic

Hepatic side effects in cancer patients have included hepatic disorder. Severe drug induced liver injury has been reported in association with histrelin.

Psychiatric

Psychiatric side effects in cancer patients have included depression and irritability.

Renal

Renal side effects in cancer patients have included renal calculus, dysuria, aggravated hematuria, aggravated renal failure, urinary frequency, aggravated urinary frequency, and urinary retention.

Respiratory

Respiratory side effects in cancer patients have included exertional dyspnea.

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