Medication Monitor

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  • 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.

  • June 11, 2019

    On May 6, 2019, FDA approved amifampridine tablets for treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 years to younger than 17 years. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is approved for use in adults.

    LEMS is a rare autoimmune disorder in which the body’s immune system attacks the neuromuscular junction and disrupts the ability of nerve cells to send signals to muscle cells. LEMS may be associated with other autoimmune diseases, but more commonly occurs in patients with cancer, such as small cell lung cancer, where its onset precedes or coincides with the diagnosis of cancer.

    LEMS can occur at any age. The prevalence of LEMS specifically in pediatric patients is not known, but the overall prevalence of LEMS is estimated to be three per million individuals worldwide.

    Use of amifampridine in patients aged 6 years to younger than 17 years is supported by evidence from adequate and well-controlled studies of the drug in adults with LEMS, pharmacokinetic data in adult patients, pharmacokinetic modeling and simulation to identify the dosing regimen in pediatric patients, and safety data from pediatric patients in that age group.

    Effectiveness for treatment of LEMS was established by a randomized, double-blind, placebo-controlled withdrawal study of 32 adult patients in which patients were taking amifampridine for at least 3 months before entering the study. The study compared patients continuing on amifampridine to patients switched to placebo. Effectiveness was measured by the degree of change in a test that assessed the time it took the patient to rise from a chair, walk 3 meters, and return to the chair for three consecutive laps without pause. The patients who continued on amifampridine experienced less impairment than those on placebo.

    Effectiveness was also measured with a self-assessment scale for LEMS-related weakness that evaluated the feeling of weakening or strengthening. The scores indicated greater perceived weakening in the patients switched to placebo.

    The most common adverse effects experienced by pediatric and adult patients taking amifampridine were burning or prickling sensation, abdominal pain, indigestion, dizziness, and nausea. Adverse effects reported in pediatric patients were similar to those seen in adult patients. Seizures have been observed in patients without a history of seizures. Patients should inform their health professional immediately if they have signs of hypersensitivity reactions such as rash, hives, itching, fever, swelling, or trouble breathing.

  • May 29, 2019

    FDA approved tafamidis meglumine and tafamidis capsules for treatment of heart disease caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Although both treatments have the same active moiety, tafamidis, they are not substitutable on a milligram to milligram basis, and their recommended doses differ.

    Efficacy of tafamidis meglumine and tafamidis in treating ATTR-CM was shown in a clinical trial of 441 patients randomized to receive tafamidis meglumine or a placebo. After an average of 30 months, the survival rate was higher in the tafamidis meglumine group than in the placebo group was also shown to reduce the number of hospitalizations for cardiovascular problems.

    The number of patients in clinical studies was small, but no drug-associated adverse effects have been identified. Tafamidis may cause fetal harm when administered to a pregnant woman. Women taking either treatment should discuss pregnancy planning and prevention with their health professional.

    ATTR is caused by the buildup of abnormal deposits of specific proteins known as amyloid in the body's organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the heart and the peripheral nervous system. Heart involvement can result in shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms and death. Involvement of the peripheral nervous system can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the kidneys, eyes, GI tract, and central nervous system.