QDOLO - (tramadol hydrochloride) oral solution
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Save with the QDOLO™ Patient Savings Card

  • QDOLO savings card


    Pay as little as $20 for 30 days*
    *Limitations apply.






    Pharmacist and Beneficiary: When you use this card, you are certifying that you have not submitted and will not submit a claim for reimbursement under any Federal, State, or other Governmental program for this prescription.

    Patient instructions:
    • Get a valid prescription for QDOLO (tramadol hydrochloride) oral solution. Your doctor will determine if QDOLO is right for you.
    • Register and activate your QDOLO Patient Savings Card below.
    • Fill your prescription by taking your QDOLO Patient Savings card and your prescription to your pharmacy.
    • Many eligible commercially insured patients will receive their prescription for $20.*

    *Program eligibility and restrictions apply. This offer is only valid for QDOLO Oral Solution 5mg/1mL, manufactured for Athena Bioscience, LLC. No substitutions permitted.

    Fill in form below to receive a printable QDOLO Patient Savings Card.
    All fields are required.
  • Athena respects individual privacy and values the confidence of our customers. The information pertaining to you that we collect will be used in accordance with our Privacy Statement. By providing your email address, you agree and acknowledge that you would like to receive information from Athena related to QDOLO and the QDOLO Patient Savings Card, including site updates, education, and other QDOLO products and services. If you later wish to opt out from receiving this information, you may click on the included opt-out link in future communications.
  • The “Copay Savings Card” constitutes an offer subject to the below “Offer Terms, Conditions, and Patient Eligibility Criteria.” This offer is not insurance. Quantity limits may apply.
  • Each patient redeeming the Copay Savings Card acknowledges and agrees as follows:
    1. The offer constituted by the Card is only made to, and can only be accepted by, a patient who is 18 years of age or older, with a valid prescription for QDOLO™ (tramadol hydrochloride) Oral Solution 5mg/1mL (“QDOLO™”), manufactured for Athena, when filled by a pharmacist at a participating pharmacy, and duly dispensed to the patient. No substitutions are permitted.
    2. Depending on applicable insurance coverage, eligible patients may receive their prescription for QDOLO™, manufactured for Athena, for $20.00 or less. Each patient accepting this offer should ask the fulfilling pharmacist to determine any applicable copay discount. Athena makes no promise, guaranty, covenant, representation, warranty or other undertaking in regard to the actual savings, if any, that a patient may receive for QDOLO™, whether in consequence of the Card or otherwise.
    3. Patient out-of-pocket expenses may vary.
    4. This offer is not valid for and may not be used by: patients enrolled in Medicare (including Part D), Medicaid, or other federal or state programs (including state pharmaceutical assistance programs, and for Puerto Rico, the Government Health Insurance Plan, formerly La Reforma de Salud, and for each any successor program); patients enrolled in private indemnity or HMO insurance plans or pharmacy benefit programs that in each instance reimburse the patient for the entire cost of a prescription drug; or patients who are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.
    5. This offer is valid for those cash-paying patients not otherwise excluded by another provision of this offer.
    6. This offer is only good for the United States of America (including its States, territories and possessions, including Puerto Rico), at participating eligible retail, specialty, or mail-order pharmacies.
    7. This offer is void wherever prohibited by law or where it is taxed or restricted.
    8. The Card is limited to one per person and is not transferable. The selling, purchasing, trading, or counterfeiting of the Card is prohibited by law. The Card has no cash value and cannot be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription.
    9. This offer neither constitutes, nor is a substitute for, health insurance. Each patient is responsible for applicable taxes, if any.
    10. Athena may rescind, revoke, amend, modify or restate this offer at any time and from time to time without notice.
    11. Certain information related to or arising from your use of the Card will be shared with Athena as the Card’s sponsor, together with Athena’s affiliates, including: the date your prescription is filled; the quantity of product dispensed to you by the pharmacist; and the amount of copay to be paid with the Card. Please see Athena’s Privacy Policy, athenabioscience.com/privacy-policy, for more information.
    12. At the time of acceptance, you are eligible for this offer, have read and understood it, and are bound by and agree to abide by its restrictions, terms, and conditions.
      13. If you have questions about the QDOLO Patient Savings Card, please call 833-469-6229.
    13. This field is for validation purposes and should be left unchanged.

QDOLO (tramadol hydrochloride) Oral Solution 5mg/1ml C-IV IMPORTANT SAFETY INFORMATION

WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, and MISUSE; RISK EVALUATION and MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL and OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.
  • QDOLO exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death.
  • The FDA has required a REMS for all opioid analgesics.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation or following a dose increase.
  • Accidental ingestion of QDOLO, especially by children, can result in a fatal overdose of tramadol.
  • Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism.
  • QDOLO is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of QDOLO in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
  • Prolonged use of QDOLO, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with QDOLO requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
  • Concomitant use of opioids with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

INDICATION

QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve QDOLO for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

  • Have not been tolerated or are not expected to be tolerated.
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia.

DOSAGE AND ADMINISTRATION

  • Ensure accuracy when prescribing, dispensing, and administering QDOLO to avoid dosing errors due to confusion between mg and mL which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed.
  • When writing prescriptions, include both the total dose in mg and the total dose in volume.
  • Instruct patients on how to measure and take the correct dose of QDOLO and to use extreme caution when measuring the dose.
  • Strongly advise patients to always use a calibrated oral syringe or other oral dosing device, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication.
  • Inform patients that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure QDOLO.
  • Do not use QDOLO concomitantly with other tramadol-containing products.
  • Do not administer QDOLO at a dose exceeding 400 mg (80 mL) per day.
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
  • Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with QDOLO and adjust the dosage accordingly.

CONTRAINDICATIONS

  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to tramadol, any other component of this product or opioids
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days

WARNINGS AND PRECAUTIONS

  • Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol.
  • Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures.
  • Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of QDOLO in patients with circulatory shock.
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of QDOLO in patients with impaired consciousness or coma.

ADVERSE REACTIONS

The most common adverse events (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Athena Bioscience, LLC at 1-833-874-2664.

See Full Prescribing Information for all adverse reactions associated with QDOLO.

DRUG INTERACTIONS

QDOLO use with Agonist/Antagonist and Partial Agonist Opioid Analgesics should be avoided as it may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.

See Full Prescribing Information for all drug interactions associated with QDOLO.

SPECIAL POPULATIONS

Pregnancy and Lactation: May cause fetal harm; breastfeeding is not recommended.

See Full Prescribing Information for use in specific populations associated with QDOLO.

Please see the accompanying Full Prescribing Information

OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)

To manage serious risks associated with opioid analgesic products, the Food and Drug Administration (FDA) requires a REMS to ensure the benefits of these products outweigh the risks of addiction, abuse, and misuse. This REMS requires providers of opioid analgesics to offer REMS-compliant education programs for healthcare providers and strongly encourages HCPs to:

  • Complete an FDA REMS-compliant accredited continuing education (CE) program
  • Counsel the safe use, serious risks, storage, and disposal of opioid analgesics with patients and caregivers
  • Emphasize to patients and caregivers the importance of reading the Medication Guide provided by their pharmacist
  • Consider other tools to improve patient, household, and community safety

For further information and a list of accredited REMS CME/CE, call 1-800-503-0784 or visit www.opioidanalgesicrems.com.

For the FDA Blueprint, visit www.fda.gov/OpioidAnalgesicREMSBlueprint.