California compliance policy summary and declaration

COMPLIANCE POLICY SUMMARY

It is the policy of Mist Pharmaceutical, LLC (“Mist”) to comply with all applicable laws and regulations and industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:

  • Written Policies and Procedures
  • Compliance Committee
  • Effective Training and Education
  • Effective Lines of Communication
  • Internal Monitoring and Auditing
  • Enforcement Through Discipline Pursuant to Published Guidelines; and
  • Prompt Response and Corrective Action for Detected Problems

Mist sales and marketing personnel interact with healthcare professionals to provide them with information about Mist products and other relevant educational or scientific topics. Mist believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Mist may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Mist may also on occasion offer modest meals to healthcare professionals in connection with educational presentations. The PhRMA Code allows pharmaceutical companies to provide “items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities.” On occasion Mist may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Mist’s Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.

California Health and Safety Code §§ 119400-119402 requires pharmaceutical companies to make available their Comprehensive Compliance Program and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California law.

ANNUAL SPEND LIMIT

Subject to this California law, Mist has determined that the annual aggregate limit on covered promotional expenditures in California is set at $500.00 per covered healthcare professional for each calendar year. This limit may be revised by Mist from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that Mist may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:

  • Drug samples provided to healthcare professionals intended for free distribution to patients;
  • Financial support for continuing medical education forums;
  • Financial support for health educational scholarships; and
  • Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.

DECLARATION OF COMPLIANCE

Mist declares, in good faith, that Mist is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. Our declaration is based upon information available during the twelve month period from January 1, 2016 through December 31, 2016. The next declaration will be based upon information captured beginning January 1, 2017.

CONCLUSION

As appropriate and consistent with applicable law, Mist will amend and make conforming changes to its Comprehensive Compliance Program. Mist is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 973-597-6202.

Important Safety Information

What is the most important information you should know about STENDRA?

STENDRA® (avanafil) is a prescription medicine used to treat erectile dysfunction (ED).

STENDRA is not for use in women or children. It is not known if STENDRA is safe or effective in women or children under 18 years of age.

Important Safety Information

What is the most important information you should know about STENDRA?

STENDRA® (avanafil) is a prescription medicine used to treat erectile dysfunction (ED).

STENDRA is not for use in women or children. It is not known if STENDRA is safe or effective in women or children under 18 years of age.

Do not take STENDRA if you take any medicines called “nitrates” or “guanylate cyclase stimulators”, as these combinations can cause your blood pressure to drop suddenly to unsafe levels. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Tell all of your healthcare providers that you take STENDRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took STENDRA.

Stop sexual activity and get medical help right away if you experience symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Who should not take STENDRA?

Do not take STENDRA if you:

  • take nitrates, often prescribed for chest pain (angina), as this may cause a sudden, unsafe drop in blood pressure
  • take guanylate cyclase stimulators such as riociguat (Adempas®), which are often used to treat pulmonary hypertension
  • take street drugs called “poppers” such as amyl nitrate and butyl nitrate
  • are allergic to STENDRA (avanafil) or any of the ingredients in STENDRA. Seek medical attention right away if you experience any symptoms of an allergic reaction such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

Before you take STENDRA, tell your healthcare provider if you:

  • have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure
  • have had heart surgery within the last 6 months
  • have pulmonary hypertension
  • have had a stroke
  • have low blood pressure, or high blood pressure that is not controlled
  • have a deformed penis shape
  • have had an erection that lasted for more than 4 hours
  • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • have ever had severe vision loss, including an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION)
  • have bleeding problems
  • have or have had stomach ulcers
  • have liver problems
  • have kidney problems or are having kidney dialysis
  • have any other medical condition

STENDRA may affect the way other medicines work.

Tell your healthcare provider about all medicines you take, including any of the following:

  • medicines called nitrates
  • medicines called guanylate cyclase stimulators such as riociguat (ADEMPAS)
  • medicines called HIV protease inhibitors such as ritonavir (NORVIR), indinavir (CRIXIVAN), saquinavir (FORTAVASE or INVIRASE) or atazanavir (REYATAZ)
  • some types of oral antifungal medicines, such as ketoconazole (NIZORAL) and itraconazole (SPORANOX)
  • some types of antibiotics, such as clarithromycin (BIAXIN), telithromycin (KETEK), or erythromycin
  • medicines called alpha-blockers. These include HYTRIN (terazosin), FLOMAX (tamsulosin HCl), CARDURA (doxazosin), MINIPRESS (prazosin HCl), UROXATRAL (alfuzosin HCl), JALYN (dutasteride and tamsulosin HCl), or RAPAFLO (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or to fainting
  • other medicines that treat high blood pressure
  • other medicines or treatments for ED

Do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking STENDRA can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What are the possible side effects of STENDRA?

The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.

Rare but serious side effects of STENDRA may include:

  • an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away
  • sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called nonarteritic anterior ischemic optic neuropathy (NAION). Stop if you have sudden vision loss in one or both eyes
  • sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness

STENDRA does not protect against pregnancy or sexually transmitted diseases, including HIV.

How should I take STENDRA?

  • The starting dose of STENDRA is 100 mg taken as early as approximately 15 minutes before sexual activity.
  • The dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken as early as approximately 30 minutes before sexual activity. The lowest effective dose should be used.
  • STENDRA may be taken with or without food.
  • Moderate consumption of alcohol is allowed (up to 3 drinks). Do not take more than 3 drinks (e.g. 3 glasses of wine or 3 shots of whiskey) when taking STENDRA.
  • Sexual stimulation is required for an erection to occur after taking STENDRA.
  • Do not take STENDRA more than once per day.
  • The safety and efficacy of combinations of STENDRA with other treatments for ED has not been studied. Therefore, the use of such combinations is not recommended.

USE ONLY AS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL

These are not all the possible side effects of STENDRA. Talk to your healthcare provider or pharmacist for more information or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch.

For more dosing information, please see accompanying full Prescribing Information and Patient Information.

Reference: 1. Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007;120(2): 151-157.