Lupron Depot® (Leuprolide Acetate) from TAP: ScriptAssist

ScriptAssist is a support program that provides a helping hand to your patients taking Lupron Depot for endometriosis or preoperative treatment of anemia in combination with iron for uterine fibroids. The service is staffed by registered nurses, and is designed to be educational and supportive. The ScriptAssist program:

Works hand-in-hand with you and your office staff
Provides relevant patient education via phone and mail
Offers dedicated nurse representatives who remain each patient's personal contact
Helps monitor treatment progress with timely reports to physicians after each contact with a patient

How to Enroll Your Patients

When you prescribe Lupron Depot, tell your patient that you're working with a nursing support service that can follow up with her to answer any questions she may have about treatment with Lupron Depot.
Please forward the following information to ScriptAssist:
- The patient's name and phone number
- Prescription information (date, prescribed dose, frequency, etc.)
- Best times to call the patient (if known)
- Can ScriptAssist leave a message? (if known)
Send referrals by:
- Email: referral@ScriptAssistLLC.com
- Fax: 1-303-333-4239
- Toll-free phone: 1-877-835-2875

Important Safety and Other Information

Prostate cancer

The most common side effect associated with Lupron Depot is hot flashes. Like other treatment options, LH-RH agonists may cause impotence. Symptoms may worsen over the first few weeks of treatment. Periodic monitoring of PSA and serum testosterone levels is recommended. Lupron Depot -4 Month 30 mg, -3 Month 22.5 mg, and 7.5 mg dosage forms are not indicated for use in women. Lupron Depot is indicated for the palliative treatment of advanced prostate cancer. Individual results may vary. Please see the full Prescribing Information for Lupron Depot -4 Month 30 mg, -3 Month 22.5 mg and 7.5 mg dosage forms and the Patient Product Information.

Endometriosis

Side effects are generally those related to hypoestrogenism, including vasomotor flushes, headaches, and vaginal dryness. After 6 months of therapy with Lupron Depot 3.75 mg, vertebral bone density decreased by an average of 3.2% compared with the pretreatment value. Lupron Depot is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. Individual results may vary. Please see the full Prescribing Information for Lupron Depot 3.75 mg and -3 Month 11.25 mg dosage forms, and the Patient Product Information for the 3.75 mg and -3 Month 11.25 mg dosage forms.

Endometriosis (add-back)

The most commonly reported side effects of Lupron Depot plus norethindrone acetate 5 mg daily are vasomotor flushes, headache, nausea/vomiting, depression/emotional lability, and asthenia. In addition, Lupron Depot plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL ratios. After treatment, mean serum lipid levels in patients with follow-up data returned to pretreatment values. Norethindrone acetate should be used with caution in women with cardiovascular risk factors including lipid abnormalities and cigarette smoking. Please refer to the norethindrone acetate prescribing information for warnings, precautions, contraindications and adverse reactions. Lupron Depot is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. Lupron Depot with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months. Individual results may vary. Please see the full Prescribing Information for Lupron Depot 3.75 mg and -3 Month 11.25 mg dosage forms, and the Patient Product Information for the 3.75 mg and -3 Month 11.25 mg dosage forms.

Uterine fibroids

Side effects are generally those related to hypoestrogenism, including vasomotor flushes, headaches, and vaginal dryness. After 3 months of therapy of Lupron Depot 3.75 mg, vertebral bone density decreased by an average 2.7% compared with the pretreatment value. Use beyond 3 months is not recommended. Lupron Depot concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata (fibroids). Individual results may vary. Please see the full Prescribing Information for Lupron Depot 3.75 mg and -3 Month 11.25 mg dosage forms, and the Patient Product Information for the 3.75 mg and -3 Month 11.25 mg dosage forms.

Central precocious puberty (CPP)

In clinical studies, the most frequent adverse event related to therapy with Lupron Depot-PED was an injection site reaction, seen in 5% of children in the combined studies. The recommended starting dose of Lupron Depot-PED is 0.3 mg/kg/4 weeks (minimum 7.5 mg). Inadequate dosing may result in poor control of the pubertal process, allowing continued sexual development; therefore, adherence to the 4-week dosing interval must be maintained. Stimulation of sexual development may occur after the first dose or if the dose is inadequate. Lupron Depot-PED is indicated in the treatment of children with central precocious puberty. Individual results may vary. Please see the full Prescribing Information and the Patient Product Information.

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