Medication Monitor



SORT BY:      Most Recent      Most Viewed     
List-View      Table-View
Generic Name (Trade Name—Company)
Notes
  • July 16, 2019

    Azurity Pharmaceuticals announced FDA approval of the first amlodipine oral suspension, 1 mg/mL, to treat hypertension in adults and pediatric patients ages 6 years and older and coronary artery disease in adults.

    The calcium channel blocker may be used alone or in combination with other antihypertensive and antianginal agents.

    It comes as a ready-to-use (simply shake) oral suspension for patients who require or prefer an oral liquid option of amlodipine. The recommended starting dose for adults is 5 mg orally once daily, with the maximum dose 10 mg once daily. For small, fragile, or older adult patients or patients with hepatic insufficiency, the starting dose is 2.5 mg once daily. The pediatric starting dose is 2.5 mg to 5 mg once daily.

    The most common adverse reaction is dose-related edema. Other adverse experiences not dose related but reported with an incidence greater than 1% are fatigue, nausea, abdominal pain, and somnolence.

     

  • 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.

Pages