DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs.Keep DYANAVEL XR in a safe place to protect it from theft. Never give your DYANAVEL XR to anyone else, because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law.

What is the most important information I should know about DYANAVEL XR?

DYANAVEL XR may cause serious side effects, including:

• Abuse, misuse, and addiction. DYANAVEL XR has a high chance of abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of DYANAVEL XR, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of DYANAVEL XR or when it is used in ways that are not approved, such as snorting or injection.

Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting, treatment with DYANAVEL XR and will monitor you or your child during treatment.DYANAVEL XR may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give DYANAVEL XR to anyone else.

Keep DYANAVEL XR in a safe place and properly dispose of any unused medicine. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

• Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with DYANAVEL XR. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DYANAVEL XR.

• Increase blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.

• Mental (psychiatric) problems, including.

○ new or worse behavior and thought problems

○ new or worse bipolar illness

○ new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with DYANAVEL XR, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Do not take DYANAVEL XR if you or your child are:

• allergic to amphetamine products or any of the ingredients in DYANAVEL XR.

• taking, or have taken within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and the intravenous medicine methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you or your child take any of these medicines.

Before taking DYANAVEL XR tell your healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart disease, heart defects, or high blood pressure

• have mental problems including psychosis, mania, bipolar illness, or depression

• have circulation problems in fingers and toes

• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome

• are pregnant or plan to become pregnant. It is not known if DYANAVEL XR will harm the unborn baby.
There is a pregnancy registry for females who are exposed to DYANAVEL XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

• are breastfeeding or plan to breastfeed. DYANAVEL XR passes into breast milk. You or your child should not breastfeed during treatment with DYANAVEL XR. Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

DYANAVEL XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with DYANAVEL XR. Especially tell your healthcare provider if you or your child take:

• MAOIs, serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants lithium, tryptophan, selective serotonin reuptake inhibitors (SSRIs), medicines used to treat migraine headaches called triptans, fentanyl, tramadol, buspirone and St. John’s Wort.

Your healthcare provider will decide whether DYANAVEL XR can be taken with other medicines. Do not start any new medicine during treatment with DYANAVEL XR without talking to your healthcare provider first.

What should I avoid during treatment with DYANAVEL XR?

You should avoid drinking alcohol during treatment with DYANAVEL XR.

What are possible side effects of DYANAVEL XR?

DYANAVEL XR may cause serious side effects, including:

• See “What is the most important information I should know about DYANAVEL XR?”

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with DYANAVEL XR. Your healthcare provider may stop your child’s DYANAVEL XR treatment if they are not growing or gaining weight as expected.

• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include: fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red.

• Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with DYANAVEL XR.

• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child gets any new or worsening tics or worsening Tourette’s syndrome during treatment with DYANAVEL XR.

• Serotonin Syndrome. This problem may happen when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop taking DYANAVEL XR and call your healthcare provider or go to the nearest hospital emergency room if you get symptoms of serotonin syndrome which may include: agitation, confusion, fast heartbeat, dizziness, flushing, tremors, stiff muscles, or muscle twitching, seizures, seeing or hearing things that are not real (hallucination), coma, changes in blood pressure, sweating, high body temperature (hyperthermia), loss of coordination, nausea, vomiting, diarrhea.

The most common side effects of DYANAVEL XR include: dry mouth, decreased appetite, weight loss, stomach pain, nausea, trouble sleeping, restlessness, extreme mood changes, dizziness and increased heart rate. These are not all of the possible side effects of DYANAVEL XR.

Call your doctor for medical advice about side effects. You may report side effects to Tris Pharma, Inc at 1-732-940-0358 OR FDA at 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning about Abuse, Misuse and Addiction and Medication Guide.