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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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:

Breast growth; bruising; constipation; decreased sex drive; erectile dysfunction (impotence); headache; hot flashes; sleeplessness; soreness, pain, tenderness, or redness at the insertion site; testicles become smaller; tiredness; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; numbness or tingling of the skin; trouble urinating or inability to urinate; weakness or loss of feeling in the legs; yellowing of the skin or eyes.

For the professional

Vantas

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 301) consisted of 138 patients, while a separate supportive study (study 302) consisted of 33 patients.

Vantas, like other LH-RH 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 301) 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).

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, hypercalcemia, 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.

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