FDA Approves First Drug For Male Erectile Dysfunction - See For Yourself

FDA Approves First Generic Viagra (sildenafil citrate) for Erectile Dysfunction

 


The U.S. Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate), for the treatment of erectile dysfunction. Teva Pharmaceutical Industries received approval to market generic sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity. For information about the availability of these products, contact the manufacturer.

Patients should talk to their doctor or pharmacist if they have heart problems, stroke in the past six months, kidney disease, liver disease, high or low blood pressure, a severe loss of body water, history of painful/prolonged erection, conditions that may increase the risk of painful/prolonged erection (such as sickle cell anemia, leukemia, multiple myeloma), and eye problems.

Generic drugs approved by FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Source: FDA

Exercise And Female Breast Density - What You Should Know

Exercise Doesn't Seem to Affect Breast Density

Researchers report that exercise does not appear to affect breast density -- a major risk factor for breast cancer.

Women with dense breasts are at increased risk for breast cancer, and physical activity is known to help protect against breast cancer. Previous research looking at a possible connection between exercise and breast density have been inconclusive.

This latest study found no link between the two. This suggests that physical activity's protective effect against breast cancer is due to other factors, according to lead researcher Shadi Azam, from the University of Southern Denmark, and colleagues.

The findings were culled from a review of the physical activity levels of more than 5,700 women in Denmark. The women were screened for breast cancer between 1991 and 2001.

The study was presented Thursday at the European Breast Cancer Conference in Amsterdam, Holland.
"We know that breast density is one of the strongest risk factors for breast cancer risk. Women with high density breasts -- more than 75 percent mammographic density -- have a four to six times' higher risk of developing the disease than do those women with a breast density of lower than 25 percent," Azam said in a conference news release.

"This is because increased breast density reduces the sensitivity of mammograms and makes it far more difficult to spot small tumors. It is also because breast density per se can lead to an increased risk of most of the cellular abnormalities that lead to breast cancer," she explained.
About 56 percent of the women in the study had mixed or dense breasts. More than 47 percent played sports, and about 70 percent cycled. Just over 50 percent of the women gardened and nearly 93 percent walked, according to the study.

Initially, the researchers noted a link between participation in sports and cycling with the odds of having denser breasts. But, when they adjusted for other potential risk factors, the association was no longer significant, Azam said.

The researchers also didn't find any big differences in breast density from walking or gardening, Azam added.

Azam noted that exercise is known to reduce breast cancer risk, and "further studies should now be focused on other mechanisms that might explain the association between physical activity and breast cancer risk."

In the meantime, women with dense breasts need to know that not everyone with dense breasts has a higher risk of breast cancer, the researchers said. If a woman is concerned about her risk of breast cancer, the researchers said there are things women can do to reduce their risk.
They recommended eating more fruits and vegetables, along with increasing physical activity. They also suggested consuming less red and processed meats, sweets, full-fat dairy and alcohol to reduce the risk of breast cancer.

If you're overweight, losing weight reduces the risk of breast cancer, and if you smoke, the researchers advised quitting.
Findings presented at meetings are generally considered preliminary until published in a peer-reviewed journal.

More information
The U.S. National Cancer Institute has more on breast cancer prevention.

Have You Considered Giving Love A Second Chance ?- A Must Read

Breakup to Makeup: Some Ways to Give Love a Second Chance

 

 

 

 

 

 

Sometimes breakups happen, even when they’re not what either of you really want. If you want to give your love a second chance, this is how to do it.

We all, one way or the other, have been in this situation. You know, the one where you breakup with your significant other only to feel worse and regret it a couple days later. Sometimes a breakup just isn’t the right solution to what you are dealing with as a couple.

This even goes for couples that have been in Splitsville for months or even years. You get reunited and want to try things again. It happens. But how do you go from breakup to makeup? Is it really that easy?

Love always deserves a second chance
Second chances are easier said than done. Couples can hold onto resentment and won’t let go of what happened in the past when the two of you actually manage to makeup—which can lead to arguments and even another breakup!
Getting back together with an ex is a huge decision to make. There are so many things that can go wrong and you’re putting your heart on the line—again. But if you believe your breakup was a mistake and you want to mend your problems and be with them again, then you should.
So if you’re serious about going from breakup to makeup with an ex, you’ll need these ways to make it happen. With these tips, a good attitude, and some love, you’ll be back together and better than ever!

1 Talk about your problems.
Obviously you two broke up for a reason and you can’t just ignore it. You have to talk about the breakup and everything that led up to it. Get all of your issues out in the open now, so you can actually have a clean slate if you both decide to get back together.
Letting old problems remain and fester after you are back together may just lead to another breakup. It’s best to talk things out, come up with a solution, and move on from it together.

2 Set boundaries.
For all intents and purposes, your relationship is new. It is fresh. It is time to set new boundaries. Talk about what you’re okay and not okay with them doing and just agree on things in general that are important to both of you.
Boundaries are a perfect way to avoid past mistakes and keep your relationship happy and healthy.

3 Be serious about it.
Don’t just jump right back into things without even thinking them through. Both of you have to take the breakup and your makeup seriously if you really want to make it work. No messing around on them just because you guys broke up and got back together.

4 Have better communication.
Bad communication is a major reason many couples end up in Splitsville. While their actual breakup may have been because of something else, that very same issue may be solved with just a little more communication.
If you really want to makeup and have a better relationship this go-round, you really need to up your communication game and clue them in on all the things that upset you and vice versa.

5 Discuss the future.
It needs to happen. If you’re getting back together, the future should be one of the first things you talk about. There’s no point in making a relationship work if you guys don’t have futures that line up.
Talk about your plans, your values, your life goals, and what you envision for your future. If the two of you find your future align well together, then it’s worth making things work. If you discover things are looking different, maybe a makeup isn’t a good plan.

6 Assess your true feelings for them.
Are you really in love with them? Or are you only upset about the breakup because you were so used to having them around and now you just feel bored or like your life is missing something?
You really have to assess your true feelings for your partner. If you can’t reciprocate the same feelings they have towards you or you realize you just don’t feel as much for them anymore, the breakup should stay permanent.

7 Take things one day at a time.
I know it’s easy to slip back into old habits as if nothing has happened, but something has: you guys broke up. Don’t take that lightly. Move slowly in your progression after getting back together.
This gives you both the time and space you need to think and feel without the other breathing down your neck. So don’t just rush back into the same old relationship—because it’s not the same. It’s new.

8 Make necessary changes in the relationship.
In order to go from breakup to makeup, you both have to make changes and really commit to them. Since something was obviously wrong and caused you to break up, you have to change whatever you need to in order to make things work.
Don’t change who you are, but if there was something causing a problem between the two of you, you have to change certain things in order to not relive those issues.

9 Don’t divulge all the dirty details.
Whether you broke up for two hours or two years, what you did in the time you were not with them is not their business. Don’t talk about what—or who—you did in that time frame. All that they need to know is you are now fully committed to getting back together with them.

10 Make sure you’re happy and you want it.
Make sure this is truly what you want. Never get back together with someone if you feel pressured to do so just because they really want you back. You will not only be unhappy in that relationship, but you’ll feel resentment toward them for making you feel that way.
The decision to go from breakup to makeup should be all yours. Even if they are pushing to get back together, the only way the relationship is going to work again is if you’re 100% committed to making it work. So put your happiness first when it comes to getting back together with your ex.

Love always deserves a second chance. Turn your relationship around and take it from breakup to makeup with these tips!
Feel free and share your romantic experience.

Protein-Heavy Meals Make You Feel Fuller, Sooner: Study

There may be something to those high-protein diets, with a new study finding that protein does make you feel full sooner.
Many people boost their uptake of meat and other protein-rich foods when trying to shed excess pounds, because they believe it will help them feel fuller while consuming fewer calories.
However, there's been a lack of large studies to confirm that idea, noted a team led by nutrition researcher Richard Mattes of Purdue University, in West Lafayette, Ind.
His team analyzed the available data from numerous studies on the issue. The new study concluded that protein does, in fact, make people feel fuller more quickly.

The findings are published March 3 in the Journal of the Academy of Nutrition and Dietetics.
"A good deal of evidence suggests that protein activates satiety [fullness] hormone release and so should be most strongly tied with fullness ratings," Mattes, director of Purdue's Ingestive Behavior Research Center, said in a journal news release.

However, "individual studies are often conducted in small populations or with different approaches that can make interpretation of results challenging. Our study combined multiple experiments to confirm the presence of an effect," he explained.
But while protein may help dieters feel full, it is not a magic bullet for weight loss, the researchers emphasized.

"Feelings like hunger and fullness are not the only factors that influence [calorie] intake," Mattes said. "We often eat for other reasons. Anyone who has ever felt too full to finish their meal but has room for dessert knows this all too well."
And just how much protein is needed to feel full?
Study co-author Heather Leidy, an assistant professor of nutrition at the University of Missouri, said that issue is still "not resolved."
Still, a moderate increase in protein intake may be a good first step for people trying to lose weight, the researchers suggested.

"If these effects are sustained over the long-term -- and our study only looked at short-term effects -- increased protein intake may aid in the loss or maintenance of body weight," Mattes said.
Two nutrition experts said the study is helpful, but the long-term effectiveness for weight loss of protein-heavy diets is still uncertain.

"While this information may be useful to spur additional studies on this topic and how it relates to calorie intake and weight, we cannot conclude that more protein means more weight loss," said Erin Keane, a nutritionist at Lenox Hill Hospital, in New York City.

"The studies [examined in the new review] differed greatly in the amount of protein eaten, as well as the amount of overall calories eaten at a given sitting," she noted. "Also, the studies did not provide insight into whether or not increased fullness actually led to decreased overall intake in a given day."
Dana Angelo White is a nutritionist and clinical assistant professor of athletic training at Quinnipiac University in Hamden, Conn. She said that the new finding "reinforces messages that registered dietitians currently give."
According to White, "The exact amount will vary, but ideally consume a variety of types of protein, both plant and animal-based, distributed throughout the day. This will not only combat hunger, it will provide the body with the amino acids it needs for things like muscle health, immunity and hormone production."

More information
The U.S. Centers for Disease Control and Prevention has more about healthy weight.

New Medication For Rheumatoid Arthritis Approved by FDA

FDA Approves Xeljanz XR

Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.

“Pfizer continues to be an innovator in inflammation and immunology. The introduction of the first and only once-daily oral JAK inhibitor for RA, Xeljanz XR, builds upon Pfizer’s tradition of developing patient-centered therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business.

“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Co-Medical Director, Metroplex Clinical Research Center.

About Xeljanz and Xeljanz XR

Xeljanz/Xeljanz XR (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. Xeljanz XR 11 mg is the first and only once-daily oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA).
As the developer of Xeljanz/Xeljanz XR, Pfizer is a leader in JAK innovation. Xeljanz/Xeljanz XR do not require injections or infusions. Xeljanz/Xeljanz XR can be taken with or without methotrexate.
Xeljanz is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of Xeljanz through a robust clinical development program. The efficacy and safety profile of Xeljanz has been studied in approximately 6,200 patients with moderate to severe RA, amounting to more than 19,400 patient-years of drug exposure in the global clinical development program.
Xeljanz is the only JAK inhibitor included in the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.¹

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints,^2,3 particularly those in the hands, feet and knees.³ Although the exact cause of RA is unknown,³ it is considered to be an autoimmune disease, because the immune system in people with RA mistakes the body’s healthy tissues for a threat and attacks them.³ Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women.⁴ Three times as many women are affected by RA compared to men.³ RA affects approximately 23.7 million people worldwide⁵ and 1.6 million people in the United States.^6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.³

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer (link is external) and @Pfizer_News (link is external), LinkedIn (link is external), YouTube (link is external) and like us on Facebook atFacebook.com/Pfizer (link is external).
DISCLOSURE NOTICE: The information contained in this release is as of February 24, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about XELJANZ and XELJANZ XR, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; whether and when any applications for XELJANZ or XELJANZ XR may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in other jurisdictions in which such applications are pending or will be submitted may approve such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov (link is external) and www.pfizer.com.

1. Singh, J. A., Saag, K. G., Bridges, S. L., et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology. doi: 10.1002/art.39480
2. Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
3. Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2015. Available athttp://www.nlm.nih.gov/medlineplus/ency/article/000431.htm (link is external).
4. Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September 2015. Available at http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors (link is external).
5. Annals of Rheumatic Diseases, “The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study.” Accessed 14 July 2015. Available at http://ard.bmj.com/content/early/2014/02/18/annrheumdis-2013-204627 (link is external).
6. Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
7. Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File 1.

Source: Pfizer Inc.

FDA Orders 'Black Box' Warning Label on Essure Long-Acting Contraceptive

A special "black box" warning should be added to packaging for the Essure implantable birth control device, based on concerns over serious complications, the U.S. Food and Drug Administration announced Monday.

The FDA also ordered Essure's manufacturer, Bayer, to conduct a new clinical study to gather more data about the health risks the device might pose for "in a real-world environment."
Essure is a permanent and nonsurgical form of birth control for women. It consists of flexible coils that are inserted through the vagina and cervix into the fallopian tubes, the FDA explained in a statement.
Scar tissue forms naturally around the coils, creating a barrier intended to prevent sperm from reaching the egg as they travel down the fallopian tubes into the uterus.
However, since the FDA approved Essure in 2002, the agency says it has received about 10,000 complaints about the device.

Complications from using Essure can include pain, abnormal bleeding, allergic reaction and tearing of the uterus or fallopian tubes if the device migrates, the FDA said.
Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, spoke about Essure during a news briefing late Monday. He said that the agency has also received 631 reports of women becoming pregnant while using the product, and 294 reports of pregnancy losses.

Still, Maisel said, "it's important for women to know that Essure is extremely effective at preventing pregnancy. However, in order for it to be effective, the device must be placed properly and women must rely on an alternative form of birth control until they undergo an Essure confirmation test."
According to Maisel, "like all forms of birth control, Essure is not perfect and women may become pregnant despite use of the device. The lack of an Essure confirmation test is the most common factor contributing to unintended pregnancies in women with Essure."

Some have alleged that clinical trial records that led to Essure's approval were altered to favor the device, but Maisel said that an FDA re-analysis of the evidence has concluded these charges are baseless.

"In the end, our analysis did not find evidence of systematic or intentional modifications of study subject responses," he said. "The agency believes the original clinical data relied upon represents valid scientific evidence."
In addition to the boxed warning, the FDA also wants Bayer to include a "patient decision checklist" in Essure's packaging, "to ensure women receive and understand information regarding the benefits and risks of this type of device."

The checklist would be reviewed and signed by the patient and her doctor. It goes over a series of health issues that should deter a woman from using Essure, and requires that she promise to return to her doctor in three months to make sure the device has been properly placed.
The clinical trial ordered by the FDA will assess rates of complications with Essure and compare them to the complications associated with tubal ligation.

The study also will evaluate how complications affect a patient's quality of life, and identify reasons why women don't come back for follow-up testing three months after insertion to make sure that Essure has been properly placed.
The public and industry will have 60 days to comment on this draft guidance from the FDA, the agency said.

More information
Visit the U.S. Food and Drug Administration for more on Essure.

New Drug for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)

FDA Approves Afinitor (everolimus) for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)

Novartis today announced that the United States Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Afinitor received a priority review designation providing a shortened review period for drugs that treat serious conditions and offer a significant improvement in safety or effectiveness.

"Afinitor is the first treatment approved for progressive, nonfunctional NET of lung origin, and one of very few options available for progressive, nonfunctional GI NET, representing a shift in the treatment paradigm for these cancers," said Bruno Strigini, President, Novartis Oncology. "We are proud of our Afinitor development program, which has translated to meaningful benefits for patients with several different cancers and rare diseases."

Neuroendocrine tumors are a rare type of cancer that originate in neuroendocrine cells throughout the body, and are most often found in the GI tract, lungs or pancreas^1,4. NET can be defined as functional or nonfunctional. Functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances. Nonfunctional NET may be characterized by symptoms caused by tumor growth, such as intestinal obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive pulmonary disease and pneumonia for lung NET^5,6,7,8. More than 70% of patients with NET have nonfunctional tumors⁹. At the time of diagnosis, 5%-44% (depending on site of tumor origin) of patients with NET in the GI tract and 28% of patients with lung NET have advanced disease, meaning the cancer has spread to other areas of the body, making it difficult to treat^1,4. Progression, or the continued growth or spread of the tumor, is typically associated with poor outcomes¹⁰.
The approval of Afinitor was based on efficacy and safety data from a pivotal study (RADIANT-4) showing Afinitor reduced the risk of progression in patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin by 52% (hazard ratio [HR] = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.001) vs placebo. Additionally, the data showed Afinitor increased median progression-free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.2-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.6-7.4) in the placebo arm³.
In the pivotal trial, the most common treatment-related grade 3/4 adverse events (AEs) (≥5%) for Afinitor and placebo, respectively, were infections (11.0% vs 2.0%), diarrhea (9.0% vs 2.0%), stomatitis (9.0% vs 0.0%), fatigue (5.0% vs 1.0%) and hyperglycemia (5.0% vs 0.0%)³.
Additional worldwide regulatory filings for this indication are underway, with a decision in the EU anticipated in 2016.

RADIANT-4 Study: Part of the largest clinical trial program in advanced NET

RADIANT-4 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. It examined the efficacy and safety of Afinitor plus best supportive care (BSC) vs placebo plus BSC in 302 patients with unresectable, progressive, well-differentiated, nonfunctional, locally advanced or metastatic NET of GI (excluding pancreatic) or lung origin. The major efficacy outcome measure of RADIANT-4 was PFS based on independent radiological assessment evaluated by Response Evaluation Criteria in Solid Tumors. Additional efficacy outcome measures were overall survival and best overall response rate (defined as complete response plus partial response)³.
Patients were randomized 2:1 to receive daily Afinitor 10 mg or daily placebo orally. All patients received BSC during treatment, which excluded somatostatin analogues (SSAs). Patients had low or intermediate grade histology, no history or active symptoms of carcinoid syndrome, had documented disease progression within the previous 6 months and were required to have ceased treatment with SSAs for 4 weeks before study entry^3,11.

The safety profile of Afinitor was consistent with what has been observed in previous studies of this drug. The most common treatment-related, all-grade AEs (incidence ≥30%) were stomatitis (63%), infections (58%), diarrhea (41%), peripheral edema (39%), fatigue (37%) and rash (30%). Afinitor was discontinued for adverse reactions in 29% of patients and dose reduction or delay was required in 70% of Afinitor-treated patients³.

About Afinitor (everolimus) tablets

Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or the lung that has progressed and cannot be treated with surgery. Afinitor is not for use in people with carcinoid tumors that actively produce hormones.

Access to Afinitor (everolimus) tablets

Novartis is committed to helping patients access our medications by offering comprehensive support programs, including Patient Assistance Now Oncology (PANO) and Afinitor CoPay programs. For more information on eligibility for these programs and how to sign up, patients and providers can visit www.Afinitor.com.

Important Safety Information

Patients should not take Afinitor if they are allergic to Afinitor or to any of its ingredients. Patients should tell their health care provider before taking Afinitor if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
Afinitor can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can even lead to death. If patients experience these side effects, they may need to stop taking Afinitor for a while or use a lower dose. Patients should follow their health care provider's instructions.
In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing. Afinitor may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.
Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with Afinitor are at a possible increased risk for a type of allergic reaction called angioedema. Patients should get medical help right away if they have trouble breathing or develop swelling of the tongue, mouth, or throat during treatment with Afinitor.
Afinitor may cause kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with Afinitor.
Afinitor can cause incisions to heal slowly or not heal well. Patients should tell their health care provider if their incision is red, warm, or painful; if they have blood, fluid, or pus in their incision; or if their incision opens up or is swollen.
Common side effects include mouth ulcers and sores. Other common side effects include infections, diarrhea, swelling of the arms, hands, feet, ankles, or other parts of the body, feeling weak or tired, rash, dry skin, itching, cough, shortness of breath, nausea, fever, weight loss, or loss of appetite.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "underway," "anticipated," "can," "may," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Afinitor (everolimus), or regarding potential future revenues from Afinitor. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Afinitor will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Afinitor will be commercially successful in the future. In particular, management's expectations regarding Afinitor could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives. We offer a broad range of medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
* The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.
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