Oxymorphone Hydrochloride and Rucaparib Camsylate

• Generic Name: oxymorphone
• Dosage Forms: n.a.
• Other Brand Names: Opana, Opana ER, Numorphan HCl

Relief of moderate to severe pain.

Symptomatic relief of moderate to moderately severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.

Extended-release tablets are used orally for management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The extended-release tablets are not intended for use on an as-needed (“prn”) basis.

In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. Optimize concomitant use of other appropriate therapies. (See Managing Opiate Therapy for Acute Pain under Dosage and Administration.)

In the management of chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Generally use opiates for management of chronic pain (i.e., pain lasting >3 months or past the time of normal tissue healing ) that is not associated with active cancer treatment, palliative care, or end-of-life care only if other appropriate nonpharmacologic and nonopiate pharmacologic strategies have been ineffective and expected benefits for both pain relief and functional improvement are anticipated to outweigh risks.

If used for chronic pain, opiate analgesics should be part of an integrated approach that also includes appropriate nonpharmacologic modalities (e.g., cognitive-behavioral therapy, relaxation techniques, biofeedback, functional restoration, exercise therapy, certain interventional procedures) and other appropriate pharmacologic therapies (e.g., nonopiate analgesics, analgesic adjuncts such as selected anticonvulsants and antidepressants for certain neuropathic pain conditions).

Available evidence insufficient to determine whether long-term opiate therapy for chronic pain results in sustained pain relief or improvements in function and quality of life or is superior to other pharmacologic or nonpharmacologic treatments. Use is associated with serious risks (e.g., opiate use disorder, overdose). (See Managing Opiate Therapy for Chronic Noncancer Pain under Dosage and Administration.)

Used parenterally as a supplement to anesthesia.

Used parenterally for analgesia during labor.

Used in patients with acute pulmonary edema for its cardiovascular effects and to allay anxiety. Should not be used in the treatment of pulmonary edema resulting from a chemical respiratory irritant.

• Generic Name: rucaparib
• Dosage Forms: n.a.
• Other Brand Names: Rubraca

Single-agent therapy for the treatment of deleterious germline and/or somatic BRCA-mutated (as detected by an FDA-approved companion diagnostic test [FoundationFocus CDx BRCA]) advanced ovarian cancer previously treated with ≥2 chemotherapy regimens (designated an orphan drug by FDA for this use). Subgroup analysis suggests overall response rate is higher in patients with platinum-sensitive disease than in those with platinum-resistant disease (66 versus 25%); no responses observed in a limited number of patients with platinum-refractory disease.

Accelerated approval based on overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Women with mutations that result in defective BRCA genes are more likely to develop ovarian cancer. Approximately 10–15% of all cases of ovarian cancer appear to be associated with these hereditary BRCA mutations.