Viadur Side Effects

Generic Name: leuprolide,leuprolide acetate

Please note - some side effects for Viadur 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 Viadur - for the Consumer

Viadur 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 Viadur Implant:

Breast tenderness; burning, redness, itching, pain, or swelling around the implant; constipation; decreased sex drive; difficulty sleeping; headache; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; dizziness or lightheadedness; increase in bone pain; muscle weakness; paralysis; severe drowsiness; severe headache; shortness of breath; trouble urinating or inability to urinate; unusual or one-sided numbness or weakness; vision changes.

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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Viadur Side Effects - for the Professional

Viadur

The safety of Viadur® was evaluated in 131 patients with prostate cancer treated for up to 24 months in two clinical trials. Viadur®, like other LHRH analogs, caused a transient increase in serum testosterone concentrations during the first 2 weeks 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 above-described clinical trials, the transient increase in serum testosterone concentrations was associated with an exacerbation of disease symptoms, manifested by pain or bladder outlet obstructive symptoms (urinary retention or frequency) in 6 (4.6%) patients.

The majority of local reactions associated with initial insertion or removal and insertion of a new implant began and resolved within the first two weeks. Reactions persisted in 9.3% of patients. 10.3% of patients developed application-site reactions after the first two weeks following insertion.

Local reactions after initial insertion of a single implant included bruising (34.6%) and burning (5.6%). Other, less frequently reported, reactions included pulling, pressure, itching, erythema, pain, edema, and bleeding.

In these two clinical trials, four patients had local infection/inflammations that resolved after treatment with oral antibiotics.

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

In the first 12 months after initial insertion of the implant(s), an implant extruded through the incision site in three of 131 patients.

The following possibly or probably related systemic adverse events occurred during clinical trials within 24 months of treatment with Viadur®, 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 Viadur® for up to 24 Months

* Expected pharmacologic consequences of testosterone suppression.
Body System	Adverse Event	Number (%)
Body as a Whole	Asthenia	10   (7.6%)
	Headache	6   (4.6%)
	Extremity pain	4   (3.1%)
Cardiovascular	Vasodilatation (hot flashes)*	89  (67.9%)
Digestive	Diarrhea	3   (2.3%)
Hematology and Lymphatic	Ecchymosis	6   (4.6%)
	Anemia	3   (2.3%)
Metabolic and Nutritional	Peripheral edema	4   (3.1%)
	Weight gain	3   (2.3%)
Nervous	Depression	7   (5.3%)
Respiratory	Dyspnea	3   (2.3%)
Skin	Sweating*	7   (5.3%)
	Alopecia	3   (2.3%)
Urogenital	Gynecomastia/breast enlargement*	9   (6.9%)
	Nocturia	5   (3.8%)
	Urinary frequency	5   (3.8%)
	Testis atrophy or pain*	5   (3.8%)
	Breast pain*	4   (3.1%)
	Impotence*	3   (2.3%)

In addition, the following possibly or probably related systemic adverse events were reported by <2% of patients using Viadur® in clinical studies.

General:  General pain, chills, abdominal pain, malaise, dry mucous membranes

Gastrointestinal:  Constipation, nausea

Hematologic:  Iron deficiency anemia

Metabolic:  Edema, weight loss

Musculoskeletal:  Bone pain, arthritis

Nervous:  Dizziness, insomnia, paresthesia, amnesia, anxiety

Skin:  Pruritus, rash, hirsutism

Urogenital:  Urinary urgency, prostatic disorder, urinary tract infection, dysuria, urinary incontinence, urinary retention

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. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least 6 months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density.

Postmarketing

Pituitary apoplexy: During post-marketing surveillance, rare 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 first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Ninety-seven of the 131 patients in the two-year duration studies that supported approval of Viadur® continued in an open-label, third-year extension study. One patient prematurely withdrew due to lack of efficacy that was attributed to a defective implant. Fifty of these patients continued in an open-label, fourth-year extension study. No spontaneous implant extrusions were reported in these extension studies. Since Viadur® has been commercially available, <1% of patients implanted have been reported to have a spontaneous implant extrusion (with or without associated infection).

Additional adverse events have been reported from US post-marketing experience with Viadur®. Because these events 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. These events have been reported infrequently and include fatigue, hypertension, migration of implant, syncope, tremor, and vomiting.

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Side Effects by Body System - for Healthcare Professionals

Endocrine

Endocrine side effects of leuprolide have included hot flashes (56% to 91%), gynecomastia (7%), breast changes (7%), breast enlargement (7%), breast tenderness (7% to 14%), decrease in testicular size, diabetes, and impotence. In addition, rare cases of pituitary apoplexy have been reported after the use of gonadotropin-releasing hormone agents.

Endocrine side effects occur in the majority of patients treated with leuprolide and are due to drug-induced hypoestrogenism and hypoandrogenism.

Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases reported, a pituitary adenoma was diagnosed. A majority of pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In those cases, pituitary apoplexy presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

Psychiatric

Psychiatric side effects have included depression and emotional lability (up to 45%), insomnia (2% to 7%), anxiety, nervousness, decreased libido (both males and females), increased libido (females), and short-term memory loss.

Nervous system

Nervous system side effects have included headache (7% to 39%), dizziness (5%), blurred vision, lethargy, paresthesias, numbness, peripheral neuropathy, spinal fracture, convulsions, transient ischemic attack, and paralysis. A case of atypical absence seizures induced by leuprolide acetate has also been reported.

Genitourinary

A number of cases of vaginal hemorrhage are reported in the literature. The presence of submucous leiomyomatas may be responsible for these events. These patients typically required emergency surgery and blood transfusions.

Massive ascites developed in one patient 3 weeks after receiving a 3.75 mg leuprolide depot injection for the treatment of leiomyomata uteri. Upon surgical resection, the uterine myomas were noted to be seeping large amounts of serous fluid.

Genitourinary side effects have included vaginal dryness (37%), urinary frequency, hematuria, ovarian hyperstimulation, testicular soreness/pain, breast soreness/tenderness,testicular atrophy, erectile dysfunction, penile disorder, reduced penis size and vaginal hemorrhage.

Cardiovascular

Cardiovascular side effects have included ECG changes (19%), ischemia (19%), peripheral edema (12%), hypertension, hypotension, murmur, phlebitis, venous and arterial thromboembolism, deep vein thrombosis, stroke, sudden cardiac death, arrhythmias, angina, pulmonary edema, pulmonary embolism, and myocardial infarction.

Gastrointestinal

Gastrointestinal side effects have included constipation (7%), anorexia (3% to 6%), nausea and vomiting (5%), weight loss, flatulence, dyspepsia, and weight gain.

Dermatologic

Dermatologic side effects have included skin rash (7%), acne, dry skin, ecchymosis, hair loss (up to 18% of females), pruritus, photosensitivity, clamminess, night sweats, increased sweating, and skin pigmentation.

Musculoskeletal

An initial increase in testosterone levels may occur during the first 2 weeks of therapy with leuprolide. An increase in bone pain, as well as worsening of other signs and symptoms of advanced prostate cancer, may be noted during this time period.

Hypoestrogenism induced by leuprolide may result in small losses in bone density. Prolonged use of leuprolide in females may increase the risk of osteoporosis.

Musculoskeletal side effects have included increased bone pain in patients with advanced prostate cancer, myalgias, arthralgias, muscle atrophy, limb pain, lower bone density scores, and tenosynovitis-like symptoms. A case of polymyositis and a case of noninflammatory myopathy have also been reported.

Hypersensitivity

A case of anaphylaxis after a single intramuscular injection of leuprolide depot is reported in the literature. On two occasions, 24 hours and 6 weeks after injection, the patient required emergency airway management. The patient continued to require regular doses of antihistamines and intermittent epinephrine injections up to 14 weeks after leuprolide administration.

Hypersensitivity reactions have included a rare report of urticaria, shortness of breath, and anaphylaxis with the depot form. Other reports of anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have also been reported in the medical literature.

Hematologic

Hematologic side effects have included anemia, leukopenia, and hemoptysis.

Respiratory

Respiratory side effects have included dyspnea, sinus congestion, cough, pleural rub, and pulmonary fibrosis.

Local

Local side effects have included erythema, ecchymosis, induration, abscess, and irritation at the site of injection.

Oncologic

Oncologic side effects have been reported including case reports of granulomas. Animal studies including an increase in benign pituitary hyperplasia and benign pituitary adenomas, an increase of pancreatic islet cell adenomas in females, and an increase of testicular cell adenomas in males have also been reported.

Other

Other side effects including symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported. Hearing disorder, hard nodule in throat, weight gain, and increased uric acid have also been reported.

Hepatic

Hepatic side effects including hepatic dysfunction have been reported.

General

General side effects including sweating, syncope, rigors, weakness, and lethargy have been reported.

Renal

Renal side effects have included difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, and aggravated nocturia.

Metabolic

Metabolic side effects have included hyperglycemia.

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