Medication Monitor

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Generic Name (Trade Name—Company)
  • August 1, 2018

    FDA approved lusutrombopag, a once-daily, orally administered, small molecule thrombopoietin receptor agonist, for treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

    Approval was based on two randomized, double-blind, placebo-controlled trials involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count of less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to 7 days.

    In one trial, 78% of patients (38/49) receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure, compared with 13% (6/48) who received placebo. In the second trial, 65% (70/108) of patients who received lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding from randomization through 7 days after the procedure, compared with 29% (31/107) receiving placebo.

    The most common adverse reaction (≥3% of patients) was headache.

    The recommended lusutrombopag dosage is 3 mg orally once daily with or without food for 7 days.

  • July 31, 2018

    FDA approved iobenguane I 131 injection for I.V. use to treat adults and adolescents aged 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed, have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use.

    Efficacy of the agent was shown in a single-arm, open-label, clinical trial in 68 patients that measured the number of patients who experienced a 5% or greater reduction of all antihypertensive medications lasting for at least 6 months. This endpoint was supported by the secondary endpoint, overall tumor response measured by traditional imaging criteria.

    The study met the primary endpoint, with 17 (25%) of the 68 evaluable patients experiencing a 50% or greater reduction of all antihypertensive medication for at least 6 months. Overall tumor response was achieved in 15 (22%) of the patients studied.

    In clinical trials, the most common severe adverse effects included lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting.

    Because it is a radioactive therapeutic agent, Iobenguane I 131 includes a warning about radiation exposure to patients and family members, which should be minimized while the patient is receiving the agent. The risk of radiation exposure is greater in pediatric patients.

    Other warnings and precautions include a risk of myelosuppression, underactive thyroid, elevations in blood pressure, renal failure or kidney injury, and pneumonitis. Myelodysplastic syndrome and acute leukemias were observed in patients who received the agent, and the magnitude of this risk will continue to be studied.

    Iobenguane I 131 can cause harm to a developing fetus; women should be advised of this potential risk and to use effective contraception after receiving the agent. Radiation exposure associated with Iobenguane I 131 may cause infertility in males and females.

  • July 27, 2018

    Abbvie announced FDA approval of elagolix, the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain—and the first FDA-approved oral treatment for this condition in more than a decade.

    Endometriosis-associated pain is often managed with medications such as oral contraceptives, NSAIDs, opioids, and hormonal therapies. These treatments can work for some women, but very few are specifically indicated for treatment of endometriosis. In more extensive cases of the disease, surgical interventions (e.g., laparotomy, laparoscopy, or hysterectomy) are often pursued and may not be curative for all individuals.

    Approval was supported by data from two replicate studies in the largest endometriosis Phase III study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain.

    Clinical trial data demonstrated that elagolix significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex. A higher proportion of women treated with elagolix 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and nonmenstrual pelvic pain compared with placebo in a dose-dependent manner at month three. Women were defined as responders if they experienced a reduction in daily menstrual pain and nonmenstrual pelvic pain with no increase in analgesic use (NSAID or opioid) for endometriosis-associated pain.

    Both elagolix treatment groups showed statistically significant greater mean decreases from baseline compared with placebo in daily menstrual pain and nonmenstrual pelvic pain at month six. Women in the Phase III studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS). Women taking elagolix 150 mg once daily and 200 mg twice daily reported a statistically (P < 0.001) significant reduction from baseline in NRS scores compared with placebo at month three.

    Data also demonstrated that women taking elagolix 200 mg twice daily showed statistically significant greater reduction in pain with sex from baseline to month three compared with placebo.

    The recommended duration of use for elagolix is up to 24 months for the 150 mg once daily dose and up to 6 months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD).  BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment.

    For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to 6 months.

    Elagolix is recommended to be taken orally at approximately the same time each day, with or without food. The new agent is expected to be available in U.S. pharmacies in early August 2018.

  • July 27, 2018

    GSK and Medicines for Malaria Venture announced FDA approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

    Tafenoquine is an 8-aminoquinoline derivative with activity against all stages of the P. vivax life cycle, including hypnozoites. It was first synthesised by scientists at the Walter Reed Army Institute of Research in 1978. 

    Approval was based on efficacy and safety data from a comprehensive global clinical development P. vivax radical cure program designed in agreement with FDA. Thirteen studies in healthy volunteers and patients directly supported the program.

    The primary evidence for clinical efficacy and safety of the 300-mg single dose was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564) involving 800 participants. Results of the two Phase III studies were announced in June 2017. The submission included data analyzed from 33 studies involving more than 4,000 trial participants treated with the 300-mg single-dose and other doses of tafenoquine.

    The most common adverse reactions (5%) observed in clinical trials were dizziness, nausea, vomiting, headache, and decreased hemoglobin.

  • July 26, 2018

    FDA has approved filgrastim-aafi, a biosimilar to Neupogen (filgrastim), under the trade name Nivestym.

    Approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nivestym compared to its reference product.

    In the United States, it is indicated for the following: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti–cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML; to reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT); for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and for chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

    Common adverse effects include aching in the bones and muscles.

    Serious risks include spleen enlargement and rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions, sickle cell crises, and kidney injury.