RELPAX^® (eletriptan HBr)

IMPORTANT SAFETY INFORMATION
As with other 5-HT₁ agonists, it is recommended that RELPAX not be given to patients with known or suspected ischemic heart disease, coronary artery disease, peripheral vascular disease, uncontrolled hypertension, severe hepatic impairment, history of cerebrovascular accident or transient ischemic attack.

RELPAX should not be administered to patients with hemiplegic or basilar migraine.

RELPAX should not be used within 24 hours of treatment with other 5-HT₁ agonists, ergot-type medication, or in patients with known hypersensitivity to eletriptan or any of its inactive ingredients.

The maximum recommended single dose of RELPAX is 40 mg. The maximum daily dose should not exceed 80 mg.

RELPAX is metabolized by the CYP3A4 enzyme; RELPAX does not inhibit or induce CYP3A4. RELPAX should not be used within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir.

Potentially life-threatening serotonin syndrome may occur with triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).

RELPAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The most common adverse events reported with RELPAX 40 mg compared with placebo were dizziness (6% vs 3%), somnolence (6% vs 4%), asthenia (5% vs 3%), and nausea (5% vs 5%).

Indication
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.

Please see full Prescribing Information.

RELPAX^® (eletriptan HBr)

Terms and Conditions

By using the RELPAX $10 Co-pay Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

• Co-pay cards are not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma De Salud"]).
• Co-pay cards are not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs.
• Patients must be 18 or older.
• By using a co-pay card, a patient may pay only $10 per prescription. Savings provided by each co-pay card are limited to $100 per month. Each co-pay card may be used once per month for twelve (12) months. Provided you continue to meet the eligibility criteria, you may be eligible to receive a second co-pay card during the offering.
• Each patient is limited to one active co-pay card at a time during this offering period and the co-pay cards are not transferable.
• You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
• The co-pay card cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription.
• The co-pay card will be accepted only at participating pharmacies.
• The co-pay card is not health insurance.
• This offer is good only in the United States and Puerto Rico.
• Pfizer reserves the right to rescind, revoke, or amend the co-pay card without notice.
• Offer valid from 4/1/11 to 12/31/13. No membership fees apply.

For help with the RELPAX $10 Co-pay Card, call 1-800-926-5334, or write:
Pfizer, ATTN: RELPAX,
PO Box 2225, Morrisville,
PA 19067-8025.
www.pfizer.com

ALSUMA^® (sumatriptan injection)

IMPORTANT SAFETY INFORMATION
Do not administer ALSUMA intravenously or intramuscularly.

Do not use ALSUMA in patients with ischemic heart disease or in patients who have symptoms of or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal variant angina), or other significant underlying cardiovascular disease, cerebrovascular syndromes (including strokes of any type as well as transient ischemic attacks), or peripheral vascular disease including ischemic bowel disease.

Do not use ALSUMA in the management of hemiplegic or basilar migraine.

Do not use ALSUMA in patients with uncontrolled hypertension because ALSUMA may increase blood pressure. ALSUMA should be administered with caution to patients with controlled hypertension, as transient increases in blood pressure with significant clinical events have been observed.

Do not use ALSUMA within 24 hours of any ergotamine-containing or ergot-type medication and/or another 5-HT₁ agonist (e.g., triptans).

Do not use ALSUMA in patients with known hypersensitivity (anaphylaxis/anaphylactoid) to sumatriptan or any of its components. Hypersensitivity reactions have occurred on rare occasions in patients receiving sumatriptan, and such reactions can be life threatening or fatal.

Serious adverse cardiac events including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, vasospasm, and death have been reported within a few hours following the administration of sumatriptan. Some of these events have occurred in patients with no prior history of cardiac disease and with documented absence of coronary artery disease (CAD).

It is strongly recommended that ALSUMA not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. It is recommended that patients who are intermittent long-term users of 5-HT₁ agonists, including ALSUMA, and who have or acquire risk factors predictive of CAD, undergo periodic cardiovascular evaluation as they continue to use ALSUMA.

Patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, or transient ischemic attacks). Some fatalities have been reported in patients who have displayed a possible primary cerebral hemorrhage, subarachnoid hemorrhage, stroke, and/or other cerebrovascular events.

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including ALSUMA, particularly during combined use with selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors and particularly during treatment initiation and dose increases.

The co-administration of ALSUMA and a monoamine oxidase A inhibitor is not generally recommended and may lead to increased sumatriptan plasma levels.

There have been rare reports of seizure following administration of sumatriptan. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

In controlled studies in migraine patients with sumatriptan injection, the most common adverse reactions (≥2% and more frequent than placebo) were injection site reactions (59% sumatriptan, 24% placebo); tingling (14%, 3%); dizziness/vertigo (12%, 4%); warm/hot sensation (11%, 4%); flushing (7%, 2%); pressure sensation (7%, 2%); feeling of heaviness (7%, 1%); burning sensation (7%, <1%); numbness (5%, 2%); feeling of tightness (5%, <1%); chest discomfort (5%, 1%); musculoskeletal weakness (5%, <1%); neck pain/stiffness (5%, <1%); drowsiness/sedation (3%, 2%); tightness in chest (3%, <1%); feeling strange (2%, <1%); tight feeling in head (2%, <1%); discomfort in nasal cavity/sinuses (2%, <1%); myalgia (2%, <1%); headache (2%, <1%), and jaw discomfort (2%, 0%).

In controlled clinical trials assessing sumatriptan injection as treatment in patients with cluster headaches, the most common adverse events compared with placebo were paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4%, 0%), and bronchospasm (1%, 0%).

In an open-label study evaluating the usability of ALSUMA, the most common adverse reactions (≥5%) were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).

ALSUMA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The use of ALSUMA in elderly patients is not recommended.

Keep ALSUMA and all medicines out of the reach of children.

Indications

ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injector for subcutaneous use is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes in adults.

ALSUMA should only be used when a clear diagnosis of migraine or cluster headache has been established. ALSUMA is not intended for the prophylactic therapy of migraine.

Please see full Prescribing Information.

ALSUMA^® (sumatriptan injection)

Terms and Conditions

By using the ALSUMA $4 Co-pay Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

• The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma De Salud"])
• The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs
• Patients must be 18 or older
• By using the Card, patients will pay only $4 per prescription. Savings are limited to $150 per month for 12 uses. The Card may be used once per month and is good for a maximum savings of $1,800 per calendar year
• You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
• The Card cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription
• The Card will be accepted only at participating pharmacies
• The Card is not health insurance
• This offer is good only in the United States and Puerto Rico
• The Card is limited to one per person during this offering period and is not transferable
• Pfizer reserves the right to rescind, revoke, or amend the Card without notice

Offer valid from 8/24/11 to 12/31/13. No membership fees apply.
For help with the ALSUMA $4 Co-pay Card, call 1-800-732-7530, or write:
Pfizer, ATTN: ALSUMA
PO Box 2229
Morrisville, PA 19067-9853
www.pfizer.com