Medical Editor: John P. Cunha, DO, FACOEP
Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride) Extended Release is a combination of an opioid agonist and an opioid antagonist used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Common side effects of Targiniq ER include:
- abdominal pain,
- back pain, or
- drug withdrawal syndrome.
Less common side effects of Targiniq ER include:
- increased tearing,
- joint pain,
- sinus headache,
- drug abuse,
- cold sweat,
- hot flashes, and
- high blood pressure (hypertension).
The starting dose of Targiniq ER for patients who are not opioid tolerant is 10 mg/5 mg orally every 12 hours. Targiniq ER may interact with other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol; skeletal muscle relaxants, pentazocine, nalbuphine, butorphanol, buprenorphine, diuretics, and anticholinergics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Targiniq ER. This drug is generally not recommended for use during pregnancy. It may harm a fetus. Babies born to mothers who have used Targiniq ER while pregnant may suffer withdrawal symptoms after birth. Oxycodone passes into breast milk. Using this drug while breastfeeding may cause undesirable effects in a nursing infant. Consult your doctor. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride) Extended Release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepine or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 2,396 patients were treated in controlled and open-label clinical studies with TARGINIQ ER. Seven hundred and ninety-four of these patients (33%) were treated for approximately six months and 621 (26%) were treated for approximately one year.
TARGINIQ ER may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see OVERDOSAGE].
Commonly Observed Treatment-Emergent Adverse Reactions In A Clinical Study With TARGINIQ ER In Opioid-Experienced Patients With Uncontrolled Moderate To Severe Chronic Low Back Pain
The safety data described in Table 4 below are based on a 12-week, randomized, double-blind, placebo-controlled clinical trial in opioid-experienced patients with moderate to severe chronic low back pain. This trial included 1,095 TARGINIQ ER-treated patients in an open-label titration period, and 298 TARGINIQ ER-and 302 placebo-treated patients in a double-blind treatment period. The mean age was 52 years old; 55% were female, and 45% were male; 74% were Caucasian, 22% were Black, and 11% were Hispanic.
The most common treatment-emergent adverse reactions (reported by ≥ 5% of TARGINIQ ER subjects) during the open-label or double-blind periods were nausea and vomiting.
The most common reason for discontinuation during the open-label period due to treatment-emergent adverse reactions (reported by ≥ 1% of subjects) was nausea (2%).
The most common reason for discontinuation during the double-blind period due to treatment-emergent adverse reactions (reported by ≥ 1% of subjects with TARGINIQ ER or placebo) was drug withdrawal syndrome ( < 1% vs. 1%), respectively.
The incidence of treatment-emergent adverse reactions reported by ≥ 2% of subjects in a clinical trial comparing TARGINIQ ER with placebo is shown in Table 4 below:
Table 4: Incidence of Treatment-Emergent Adverse
Reactions Reported in ≥ 2% of Subjects Taking TARGINIQ ER: Safety
Population (Open-Label Titration Period) and Randomized Safety Population
|MedDRA System Organ Class Preferred Term||Open-Label Period||Double-Blind Period|
|*Drug withdrawal syndrome||1||2||3|
|*Percentages in the table are based on adverse reaction reports of Drug Withdrawal Syndrome in the key efficacy and safety study. In addition to the adverse reaction reports, an independent Adjudication Committee identified additional subjects with possible drug withdrawal syndrome, resulting in a total (adverse reactions plus adjudicated cases) of 2% of subjects in the Open-Label Period, and in the Double-Blind Period 4% of subjects treated with TARGINIQ ER and 2% treated with placebo.|
In a clinical trial, the following adverse reactions were reported in patients treated with TARGINIQ ER with an incidence between ≥ 1% and < 2%:
Eye disorders: lacrimation increased
General disorders and administration site conditions: fatigue
Infections and infestations: influenza
Injury, poisoning, and procedural complications: fall
Musculoskeletal and connective tissue disorders: arthralgia
Psychiatric disorders: drug abuse
The following most frequently reported adverse reactions have been identified during post-approval use of oxycodone/naloxone extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: abdominal pain, constipation, diarrhea, nausea, and vomiting
General Disorders and Administration Site Conditions: drug withdrawal syndrome, fatigue, pain, malaise, and drug ineffective
Injury, Poisoning, and Procedural Complications: inadequate analgesia
Neoplasms Benign, Malignant, and Unspecified (including cysts and polyps): malignant neoplasm progression
Nervous System Disorders: dizziness, headache, tremor, and somnolence
Psychiatric Disorders: restlessness, confusional state, and anxiety
Respiratory, Thoracic, and Mediastinal Disorders: dyspnea
Skin and Subcutaneous Tissue Disorders: hyperhidrosis and pruritus
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in TARGINIQ ER.
Read the entire FDA prescribing information for Targiniq ER (Oxycodone Hydrochloride and Naloxone Hydrochloride Extended Release Tablets)