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Answers to common questions about ONYDA™ XR

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Find answers to common questions about ONYDA™ XR (clonidine HCl)

ONYDA XR is the first once-nightly, extended-release liquid clonidine used for the treatment of ADHD. ONYDA XR is a non-stimulant prescription liquid medicine that is taken by mouth once daily at bedtime, with or without food. ONYDA XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if ONYDA XR is safe and effective in children under 6 years of age.

The “XR” stands for “eXtended Release.”

ONYDA XR uses technology to allow for a continuous release of clonidine throughout the day. This means that ONYDA XR only needs to be taken once each day at bedtime.

There is a generic clonidine XR hydrocholide tablet that is taken twice a day. ONYDA XR is different and is approved as once a day use. Please ensure that you are receiving ONYDA XR from your pharmacist and not a substitute if your doctor specifically prescribed ONYDA XR.

Monotherapy:

  • The effectiveness of clonidine XR has been assessed in a clinical study in children 6 to 17 years old with ADHD. Patients were randomly assigned to 1 of 3 treatment groups: clonidine XR 0.2 mg/day, clonidine XR 0.4 mg/day, or placebo, and for those who were given clonidine the dose was gradually increased until they had reached their fixed doses. Patients remained on the medication for eight weeks while others took a placebo. Each week, each child's attention and behavior was measured using ADHD-RS-IV scores.1
  • At week 5, patients in the clonidine XR groups had significantly greater improvement in inattention and hyperactivity scores from baseline than those in the placebo group.1
  • The most common adverse events in the study were somnolence, fatigue, irritability, pharyngolaryngeal pain, increased body temperature, ear pain, emotional disorder, nightmare, insomnia, constipation and dry mouth.1

Combined with stimulants:

  • The effectiveness of clonidine XR has been assessed in a clinical study in children 6 to 17 years old with ADHD who had been previously treated with stimulants and had inadequate response. In combination with their baseline stimulant medication, each patient was given either placebo or clonidine XR and the dose of clonidine XR was gradually titrated until they had reached their flexible doses. Each child's attention and behavior was measured weekly using ADHD-RS-IV scores.2
  • At 5 weeks, patients in the clonidine XR + stimulant group improved from baseline in ADHD symptoms measured by ADHD-RS-IV scores compared to those taking placebo + stimulant.2
  • The most common adverse events in the study were somnolence, fatigue, headache, upper abdominal pain, nasal congestion, pharyngolaryngeal pain, cough, irritability, insomnia, dizziness, and increased body temperature.2

Based on the results for clonidine XR, ONYDA XR may be used as monotherapy or combined with stimulants to treat ADHD.

ONYDA XR is orange-flavored.

  • Store ONYDA XR at room temperature between 68°F to 77°F (20°C to 25°C).
  • Throw away (discard of) any remaining ONYDA XR if you have not used it after 60 days of first opening the bottle.
  • Keep ONYDA XR and all medicines out of the reach of children.

ONYDA XR is supplied in a bottle of 30 mL and a bottle of 60 mL with one oral dosing dispenser and one press in bottle adapter.

  • Take ONYDA XR once daily at bedtime with or without food
  • Take ONYDA XR exactly as your healthcare provider tells you. Your healthcare provider may change your dose of ONYDA XR. Do not change your dose of ONYDA XR without talking to your healthcare provider
  • If you take too much ONYDA XR, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away

Take ONYDA XR exactly as prescribed by your doctor and as instructed by your pharmacist. ONYDA XR is taken once each day at bedtime

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ADHD, Attention Deficit Hyperactivity Disorder

REFERENCES: 1. Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. 2. Kollins SH, Jain R, Brams M, Segal S, Findling RL, Wigal SB, Khayrallah M. Clonidine extended-release tablets as add-on therapy to psychostimulants in children and adolescents with ADHD. Pediatrics. 2011 Jun;127(6):e1406-13.

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Important Safety Information

ONYDA™ XR (clonidine HCI) is a prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) alone or with certain other ADHD medicines in children 6 years of age and older. It is not known if ONYDA XR is safe and effective in children under 6 years of age.

See Additional Important Safety Information.

APPROVED USE

ONYDA™ XR (clonidine HCI) is a prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) alone or with certain other ADHD medicines in children 6 years of age and older.

It is not known if ONYDA XR is safe and effective in children under 6 years of age.

Important Safety Information

Who should not take ONYDA XR?

  • Do not take ONYDA XR if you are allergic to clonidine.

ONYDA XR can cause serious side effects including:

  • Allergic reactions: You may develop an allergic reaction to ONYDA XR if you had an allergic reaction to clonidine taken through your skin in a patch. Stop taking ONYDA XR and call your healthcare provider right away or go to the nearest emergency room if you develop any signs or symptoms of an allergic reaction, including:
    • dizziness
    • hives
    • swelling of the eyes, face, lips, or tongue
  • Decreased blood pressure and heart rate. ONYDA XR can decrease your blood pressure and heart rate, which can increase your chance of passing out (syncope). If you have a history of passing out or have other medical problems as mentioned above, your risk is higher. Your healthcare provider should check your heart rate and blood pressure before starting treatment and regularly during treatment with ONYDA XR. Do not become dehydrated or too hot (overheated) to decrease your chance of passing out during treatment with ONYDA XR. Before taking ONYDA XR, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems, have low or high blood pressure, have heart problems, including slow heart rate or other heart rhythm problems, had a stroke or have stroke symptoms.
  • Sleepiness and tiredness that could cause slow reaction times (sedation and somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how ONYDA XR affects you because ONYDA XR can cause sleepiness and tiredness that could cause slow reaction times. Do not drink alcohol or take other medicines that make you sleepy or dizzy during treatment with ONYDA XR until you talk with your healthcare provider.
  • Rebound high blood pressure (hypertension). Suddenly stopping ONYDA XR can cause high blood pressure to return if you have a history of high blood pressure. Suddenly stopping ONYDA XR may also cause withdrawal symptoms including headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, tightness in your chest and nervousness or anxiety. Do not suddenly stop ONYDA XR treatment without first talking to your healthcare provider.

The most common side effects of ONYDA XR when used alone include:

  • falling asleep or sleepiness and tiredness that could cause slow reaction times
  • irritability
  • nightmare
  • trouble sleeping
  • constipation
  • dry mouth

The most common side effects of ONYDA XR when used with other ADHD medicines include:

  • falling asleep or sleepiness and tiredness that could cause slow reaction times
  • decreased appetite
  • dizziness

ONYDA XR may cause fertility problems in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of ONYDA XR. Call your doctor for medical advice about side effects.

ONYDA XR and certain other medicines may affect each other causing serious side effects. Especially tell your healthcare provider if you take:

  • anti-depression medicines
  • heart or blood pressure medicines
  • other medicines for ADHD
  • other medicines that contain clonidine
  • medicines that cause sleepiness (sedation)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.

Know the medicines that you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

Before taking ONYDA XR, tell your healthcare provider, if you:

  • are pregnant or plan to become pregnant. It is not known if ONYDA XR will harm the unborn baby.
    There is a pregnancy registry for females who are exposed to ADHD medications, including ONYDA XR, during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ONYDA XR and their baby. If you become pregnant during treatment with ONYDA XR, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhdmedications/.
  • are breastfeeding or plan to breastfeed. ONYDA XR passes into the breast milk. Babies who are breastfed during treatment with ONYDA XR may become very sleepy, develop relaxed or floppy muscles, and develop trouble breathing. Call the baby’s healthcare provider if the baby is breastfed during treatment with ONYDA XR and develops any of these symptoms. Talk to your healthcare provider about the best way to feed your baby if you take ONYDA XR.

To report side effects, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information and Patient Information, including Instructions for Use.

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