Medication Monitor



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  • July 8, 2019

    Retrophin announced FDA approval of 100-mg and 300-mg tablets of tiopronin, a new enteric-coated formulation, for treatment of cystinuria. This rare inherited disorder causes a buildup of cystine levels in the urine, resulting in the formation of recurring cystine kidney stones. 

    The new formulation can be administered with or without food, whereas the original formulation of 100 mg tiopronin is recommended to be taken at least 1 hour before or 2 hours after meals.

    The recommended initial dosage of tiopronin in adult patients is 800 mg per day. In clinical studies, the average dose was approximately 1,000 mg, or 10 tablets per day.

    The most common adverse reactions are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.

  • July 1, 2019

    FDA approved an expanded use of avatrombopag for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 

    Avatrombopag was previously approved for treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.  

    The drug is an oral thrombopoietin receptor agonist administered with food.

    In the pivotal Phase III study, administration of avatrombopag resulted in a platelet count of at least 50,000 per µL at day eight of therapy in the majority of patients. Efficacy was superior to placebo in maintaining platelet counts in the target range during the 6-month treatment period. 

    The most common adverse reactions in patients with chronic immune thrombocytopenia are headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.

    Full prescribing information is available at www.Dova.com.

  • July 1, 2019

    Pfizer has received FDA approval for bevacizumab-bvzr, a biosimilar to bevacizumab (Avastin), for treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent, or metastatic cervical cancer.

    It works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein. 

    FDA approval was based on review of a comprehensive data package that demonstrated biosimilarity of bevacizumab-bvzr to the reference product.

    The most common adverse reactions are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

    See the prescribing information for dosage instructions.

  • June 28, 2019

    Janssen announced FDA approval of daratumumab in combination with lenalidomide and dexamethasone (Rd) for treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

    Approval was based on results from the Phase III MAIA (MMY3008) clinical study, which showed that daratumumab-Rd significantly reduced the risk of disease progression or death by 44% percent compared with treatment with Rd alone.

    The most frequent (≥20%) adverse reactions were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea and cough.

    Serious adverse reactions were pneumonia, bronchitis, and dehydration.

  • June 28, 2019

    Eculizumab injection for I.V. use has gained a new indication as the first treatment for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are positive for the anti-aquaporin-4 (AQP4) antibody. NMOSD is a CNS autoimmune disease that mainly affects the optic nerves and spinal cord.

    Effectiveness of eculizumab for treatment of NMOSD was demonstrated in a clinical study of 143 patients with NMOSD who had antibodies against AQP4 (anti-AQP4 positive) and were randomized to receive either eculizumab treatment or placebo. The study showed that compared with placebo, treatment with eculizumab reduced the number of NMOSD relapses by 94% over the 48-week course of the trial. The agent also reduced the need for hospitalizations and for treatment of acute attacks with corticosteroids and plasma exchange.

    Eculizumab has a boxed warning cautioning that life-threatening and fatal meningococcal infections have occurred and that such infections may become rapidly life-threatening or fatal if not recognized and treated early. Patients should be monitored for early signs of meningococcal infections and evaluated immediately if infection is suspected. Use should be discontinued in patients who are being treated for serious meningococcal infections. Health professionals should use caution when administering eculizumab to patients with any other infection. In the NMOSD clinical trial, no cases of meningococcal infection were observed.

    Eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must enroll in the REMS program and counsel patients about the risk of meningococcal infection, give patients the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

    The most frequently reported adverse reactions are upper respiratory infection, common cold, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and contusion.

    The agent was first approved by FDA in 2007 for treatment of adults with paroxysmal nocturnal hemoglobinuria; for treatment of adults and children with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy; and for treatment of adults with myasthenia gravis who are positive for the anti-acetylcholine receptor antibody.

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