Medication Monitor

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  • July 16, 2019

    FDA has approved Grifol's 20% immunoglobulin for S.C. injection to treat primary humoral immunodeficiency in patients ages 2 years and older. It can also be used to treat rare neurological conditions, such as chronic inflammatory demyelinating polyneuropathy.

    The product has a boxed warning on the risk of thrombosis. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, clinicians should administer at the minimum dose and infusion rate practicable, and ensure adequate hydration before administration. Clinicians should also monitor for signs and symptoms of thrombosis, and assess blood viscosity in patients at risk for hyperviscosity.

    Common adverse reactions are infusion site erythema, pain, swelling, bruising, nodule, pruritus, induration, scab, and edema; as well as systemic reactions such as cough and diarrhea.

    Grifols plans to launch the product in the United States in the last quarter of 2019.


  • July 8, 2019

    FDA granted accelerated approval to selinexor tablets in combination with the corticosteroid dexamethasone for treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

    Efficacy was evaluated in 83 patients with RRMM who were treated with selinexor in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was 4 weeks, with a range of 1 to 10 weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.

    Common adverse effects of patients taking selinexor in combination with dexamethasone included leukopenia, neutropenia, thrombocytopenia, and anemia. Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections, and low blood sodium levels.

    Health professionals are advised to monitor patients for low blood counts, platelets, and sodium levels. Patients should avoid taking selinexor with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. Health professionals also are advised to optimize the patient’s hydration status, blood counts, and other medications to avoid dizziness or confusion.

    Females of reproductive age and males with a female partner of reproductive potential should use effective contraception during treatment. Women who are pregnant or breastfeeding should not take selinexor because it may cause harm to a developing fetus or newborn baby. Selinexor must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

  • June 25, 2019

    FDA has approved bremelanotide to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

    HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Acquired HSDD develops in a patient who previously experienced no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation, or partner.

    Bremelanotide activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown. Patients inject bremelanotide under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity and may decide the optimal time to use bremelanotide based on how they experience the duration of benefit and any adverse effects, such as nausea. Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after 8 weeks if they do not report an improvement in sexual desire and associated distress.

    Effectiveness and safety of bremelanotide were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. Most patients used bremelanotide two or three times per month and no more than once a week. In these trials, about 25% of patients treated with the medication had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared with about 17% of those who took placebo.

    In addition, about 35% of the patients treated with bremelanotide had a decrease of one or more in their distress score (scored on a range of 0 to 4, with higher scores indicating greater distress from low sexual desire) compared with about 31% of those who took placebo. There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. The medication does not enhance sexual performance.

    The most common adverse effects are nausea and vomiting, flushing, injection-site reactions, and headache. About 40% of patients in the clinical trials experienced nausea, most commonly with the first injection, and 13% needed medications for treatment of nausea. About 1% of patients reported darkening of the gums and parts of the skin, including the face and breasts, which did not go away in about one-half the patients after stopping treatment. Patients with dark skin were more likely to develop this adverse effect.

    In the clinical trials, the drug increased blood pressure after dosing, which usually resolved within 12 hours. Because of this effect, bremelanotide should not be used in patients with high blood pressure that is uncontrolled or in those with known cardiovascular disease. It is also not recommended in patients at high risk for cardiovascular disease.

    When naltrexone is taken by mouth, bremelanotide may significantly decrease the levels of naltrexone in the blood. Patients who take a naltrexone-containing medication by mouth to treat alcohol or opioid dependence should not use bremelanotide because it could lead to naltrexone treatment failure.

  • June 25, 2019

    In a June 6 news release, Exeltis USA announced FDA approval of drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.

    The progestin-only pill (POP) is a novel estrogen-free oral contraceptive with a dosing regimen of 24 active with 4 inactive tablets. It also allows a 24-hour missed-pill window.  

    In clinical trials, drospirenone, a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone, showed no instances of thromboembolic events experienced by some women taking combined oral contraceptives, which by definition contain estrogen. It was approved with no black box warning, unlike other combined oral contraceptives. But for females with conditions that predispose to hyperkalemia (e.g., renal impairment, hepatic impairment, and adrenal insufficiency), drospirenone is contraindicated because of its anti-mineralocorticoid activity.

    This safety profile was demonstrated for all patients, including higher-risk populations such as smokers, older women, and those with a BMI greater than 30.

    Contraindications include renal impairment, adrenal insufficiency, presence or history of progestin-sensitive cancers, liver tumors (benign or malignant) or hepatic impairment, or undiagnosed abnormal uterine bleeding.

    A commercial launch is planned for early fall 2019.


  • June 22, 2019

    FDA granted accelerated approval to polatuzumab vedotin-piiq as the first chemoimmunotherapy regimen to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. DLBCL is the most common type of non-Hodgkin lymphoma.

    The drug is used in combination with the chemotherapy drug bendamustine and a rituximab product (a combination known as “BR”). Polatuzumab vedotin-piiq is an antibody that is attached to a chemotherapy drug. It binds to the CD79b protein found only on B cells, then releases the chemotherapy drug into those cells.

    The most common adverse effects of the drug plus BR include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite, and pneumonia. Health professionals are advised to monitor patients closely for infusionrelated reactions, low blood counts, and fatal or serious infections. They should also monitor patients for tumor lysis syndrome, liver damage, and progressive multifocal leukoencephalopathy, a fatal or lifethreatening infection of the brain.

    Women of reproductive age should use effective contraception during treatment and for 3 months after the last dose. Women who are pregnant or breastfeeding should not take the drug because it may cause harm to a developing fetus or newborn baby.