WARNING: POST TREATMENT WORSENING OF HEPATITIS B
If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B Virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking SYMFI LO. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with SYMFI LO.
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This SAVINGS card can be used to reduce the amount of your out-of-pocket expense for Symfi Lo™ up to a maximum of $6000 per calendar year with no monthly limit through December 31, 2018. Valid prescription with Prescriber ID# required.
Eligibility Requirements: This SAVINGS card can be redeemed only by patients or patient guardians who are 18 years of age or older and who are residents of the United States and its territories. Patients must have commercial insurance. Not valid for uninsured patients (but may be used by commercially insured patients without coverage for Symfi Lo) and patients who are covered by any state or federally funded healthcare program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare (regardless of whether Symfi Lo is covered by such government program); not valid if the patient is Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; and not valid if the patient’s insurance plan is paying the entire cost of this prescription. Void outside the US and its territories or where prohibited by law, taxed, or restricted. This program is valid in Massachusetts through June 30, 2019, unless otherwise amended or extended by Massachusetts.
This SAVINGS card is not health insurance. The SAVINGS card is not transferable and the amount of the benefit cannot exceed the patient’s out-of-pocket expenses. Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. This SAVINGS card is not redeemable for cash. Mylan Specialty L.P. reserves the right to amend or end this program at any time without notice.
NOTICE: Data related to your use of this SAVINGS card may be collected, analyzed and shared with Mylan Pharmaceuticals for market research and other purposes related to assessing coupon programs. Data shared with Mylan Specialty L.P. will be aggregated and de-identified, meaning it will be combined with data related to other SAVINGS card redemptions and will not identify you.
Patient Instructions: Present your SAVINGS card and prescription drug insurance card, along with a valid prescription for the Symfi Lo by using this SAVINGS card, you acknowledge that you currently meet the eligibility criteria and that you understand and will comply with the following additional terms and conditions:
Pharmacist Instructions: When you use this SAVINGS card, you are certifying that you have received this SAVINGS card from an eligible patient; you have dispensed the product as indicated; you have not submitted and will not submit a claim for reimbursement under any federal, state or other governmental programs for this prescription; and you will otherwise comply with these terms and all applicable terms and conditions. You further certify that your participation in this program is consistent with all applicable state laws and any obligations, contractual or otherwise, that you have as a pharmacy provider, and that you will report the use of this SAVINGS card to the patient’s insurer if required.
What is the most important information I should know about SYMFI LO?
SYMFI LO can cause serious side effects, including:
Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death.
Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
Severe liver problems. In some cases, severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Inflammation of your liver (hepatitis) that can lead to liver failure requiring a liver transplant has been reported in some people treated with SYMFI LO. Your healthcare provider may do blood tests to check your liver before and during treatment with SYMFI LO.
Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: your skin or the white part of your eyes turns yellow (jaundice), dark or “tea-colored” urine, light-colored stools (bowel movements), confusion, tiredness, loss of appetite for several days or longer, nausea and vomiting, pain, aching or tenderness on the right side of your stomach-area, weakness, stomach (abdomen) swelling.
Worsening of hepatitis B infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B Virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking SYMFI LO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with SYMFI LO.
It is not known if SYMFI LO is safe and effective in people who have both HIV-1 and HBV infection.
Do not run out of SYMFI LO. Refill your prescription or talk to your healthcare provider before your SYMFI LO is all gone.
Do not stop SYMFI LO without first talking to your healthcare provider. If you stop taking SYMFI LO, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with SYMFI LO. Tell your healthcare provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.
Serious mental health problems. Get medical help right away if you get any of the following symptoms: feel sad or hopeless, feel anxious or restless, do not trust other people, hear or see things that are not real, are not able to move or speak normally, have thoughts of hurting yourself (suicide) or have tried to hurt yourself or others, are not able to tell the difference between what is real and what is false or unreal.
Do not take SYMFI LO if you: are allergic to efavirenz, lamivudine, tenofovir disoproxil fumarate, or any of the ingredients in SYMFI LO or are currently taking elbasvir and grazoprevir commonly known as Zepatier®.
Before you take SYMFI LO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, including hepatitis B or C infection, have kidney problems, including end-stage renal disease (ESRD) that requires dialysis, have a history of mental health problems, have a history of drug or alcohol abuse, have a heart problem, including QT prolongation, have bone problems, including a history of bone fractures, have a history of seizures, are breastfeeding or plan to breastfeed, are pregnant or plan to become pregnant. SYMFI LO may harm your unborn baby. You should not become pregnant during treatment with SYMFI LO. Tell your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with SYMFI LO. Females who can become pregnant should use effective birth control during treatment with SYMFI LO and for 12 weeks after stopping treatment. A barrier form of birth control should always be used along with another type of birth control. If you can become pregnant, your healthcare provider should do a pregnancy test before you start SYMFI LO.
Pregnancy Registry. There is a pregnancy registry for women who take SYMFI LO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines interact with SYMFI LO. SYMFI LO may affect the way other medicines work, and other medicines may affect how SYMFI LO works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with SYMFI LO. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take SYMFI LO with other medicines.
What are the possible side effects of SYMFI LO?
SYMFI LO may cause serious side effects, including:
See "What is the most important information I should know about SYMFI LO?"
Nervous system symptoms are common in people who take SYMFI LO, but can be severe. These symptoms usually begin during the first or second day of treatment with SYMFI LO and usually go away after 2 to 4 weeks of treatment. These symptoms may become worse if you drink alcohol or take a medicine for mental health problems. Symptoms may include: dizziness, trouble concentrating, trouble sleeping, unusual dreams, drowsiness, hallucinations. If you get nervous system symptoms during treatment with SYMFI LO, you should avoid driving, operating machinery, or doing anything that needs you to be alert.
Skin reactions and allergic reactions. Skin reactions or rash can happen and can sometimes be severe. Skin rash usually goes away without any change in treatment. If you develop a rash or a rash with any of the following symptoms, call your healthcare provider right away: itching, fever, swelling of your face, blisters or skin lesions, peeling skin, mouth sores, red or inflamed eyes.
Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with HIV-1 and hepatitis C virus who were taking antiretroviral medicines for HIV-1 and were also being treated for hepatitis C with interferon alfa with or without ribavirin. If you are taking SYMFI LO and interferon alfa with or without ribavirin, tell your healthcare provider if you have any new symptoms.
Seizures. Seizures are more likely to happen if you have had seizures in the past.
Increases in blood fat levels (cholesterol and triglycerides). Your healthcare provider will check your blood fat levels before and during treatment with SYMFI LO.
Bone problems can happen in some people who take SYMFI LO. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. Tell your healthcare provider if you have any bone pain, pain in your hands or feet, or muscle pain or weakness during treatment with SYMFI LO.
Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with SYMFI LO if they: have taken nucleoside analogue medicines in the past, have a history of pancreatitis, have other risk factors for pancreatitis. Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving SYMFI LO to your child if their symptoms and blood test results show that your child may have pancreatitis.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.
Changes in body fat can happen in some people who take HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with SYMFI LO.
The most common side effects of SYMFI LO are rash and dizziness.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SYMFI LO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SYMFI LO is a prescription medicine that is used without other antiviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people weighing at least 35 kg. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). SYMFI LO contains the prescription medicines efavirenz, lamivudine and tenofovir disoproxil fumarate. SYMFI LO is not for use in children weighing less than 35 kg.
For additional information please contact us at 800-395-3376.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.
Symfi Lo™ is a trademark of Mylan Pharmaceuticals. The Mylan logo is a registered trademark of Mylan Inc. All other trademarks and service marks are the property of their respective owners.
© 2018 Mylan Specialty L.P. All rights reserved. 3/18 SYM-2018-0001