A MONTHLY DOSE OF EDUCATION

Transcription

1 A MONTHLY DOSE OF EDUCATION Brian Pelletier, PharmD, BCGP, FASCP CEO, A Dose of Education, LLC October/November 2017 FDA Approval Abilify Mycite (aripiprazole tablets with sensor) approved 11/13/2017 (New dosage form) Drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion Indicated for: Treatment of adults with schizophrenia Treatment of bipolar I disorder: Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate Adjunctive treatment of adults with major depressive disorder (MDD) 1

2 Abilify Mycite Formulation / Administration: Tablets with sensor: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg Administer once daily without regard to meals Swallow whole; do not divide, crush, or chew Warnings/Precautions: The ability of Abilify Mycite to improve patient compliance or modify aripiprazole dosage has not been established. Use to track drug ingestion in real-time or during an emergency is not recommended because detection may be delayed or not occur Abilify Mycite Drug Interactions: 2

3 Abilify Mycite Adverse Reactions: All previous ADRs remain unchanged (some specific info noted below) Includes Black box warning for elderly patients with dementia-related psychosis and suicidal thoughts and behaviors Commonly observed (incidence 5% and at least twice that for placebo) in adult patients: Schizophrenia: akathisia Bipolar mania (monotherapy): akathisia, sedation, restlessness, tremor, and extrapyramidal disorder Bipolar mania (adjunctive therapy with lithium or valproate): akathisia, insomnia, and extrapyramidal disorder MDD (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision FDA Approval Fasenra (benralizumab) approved 11/8/17 An interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Adverse Reactions: Most common (incidence greater than or equal to 5%) include headache and pharyngitis 3

4 Fasenra (benralizumab) Formulation / Administration: Injection: 30mg/mL solution in a single-dose prefilled syringe (see below) Administer by subcutaneous injection Recommended dose is 30mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter Fasenra (benralizumab) Warnings/Precautions: Not for treatment of other eosinophilic conditions Not for relief of acute bronchospasm or status asthmaticus Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after. Discontinue in the event of a hypersensitivity reaction. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with. Decrease corticosteroids gradually, if appropriate. Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy. If patients become infected while receiving Fasenra and do not respond to anti-helminth treatment, discontinue until the parasitic infection resolves. 4

5 FDA Approval Prevymis (letermovir) approved 11/14/17 A CMV DNA terminase complex inhibitor Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) Formulation / Administration: Tablet: 240mg; 480mg Injection: 240mg/12mL (20mg/mL) or 480mg/24mL (20mg/mL) in a single-dose vial Usual Dosing: 480mg administered once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant Prevymis (letermovir) Dose adjustments: If co-administered with cyclosporine, the dosage should be decreased to 240mg once daily Closely monitor serum creatinine levels in patients with CLcr less than 50mL/min Not recommended for patients with severe (Child-Pugh C) hepatic impairment Contraindicated with: Pimozide Ergot Akaloids Pitavastatin and simvastatin when co-administered with cyclosporine 5

6 Prevymis (letermovir) Other Drug Interactions: Prevymis is a moderate inhibitor of CYP3A and of OATP1B1/3 transporters Can increase concentrations of the following medications: Amiodarone HMG Co-A Reductase Inhibitors CYP3A substrates Can decrease concentrations of the following medications: Warfarin Phenytoin Omeprazole / Pantoprazole Administration with rifampin is NOT recommended Prevymis (letermovir) Adverse Reactions: Most common are nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain 6

7 FDA Approval Vyzulta (latanoprostene bunod ophthalmic solution) approved 11/2/17 A prostaglandin analog Indicated for the reduction of intraocular pressure in patients with openangle glaucoma or ocular hypertension Formulation / Administration: Topical ophthalmic solution: 0.24 mg/ml latanoprostene bunod (0.024%) One drop in the affected eye(s) once daily in the evening Contact lenses should be removed prior to the administration because this product contains benzalkonium chloride. Lenses may be reinserted 15 minutes after administration Vyzulta (latanoprostene bunod ophthalmic solution) Storage Unopened bottle should be stored refrigerated at 2-8 (36-46 ). Once a bottle is opened it may be stored at 2-25 (36-77 ) for 8 weeks Warnings/Precautions: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment Adverse Reactions: Most common ocular adverse reactions with incidence 2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%) 7

8 Another Me Too Drug? Vyzulta is nearly identical to that of latanoprost Distinguished, however, by the integration of an NO-donating moiety (a terminal butyl nitrate ester functional group) in lieu of an isopropyl ester Hydrolyzed by endogenous corneal esterases into latanoprost acid the active component of latanoprost and butanediol mononitrate, which is further metabolized to NO and the inactive 1,4-butanediol Clin Ophthalmol. 2016; 10: FDA Approval Juluca (dolutegravir; rilpivirine) approved 11/21/17 A two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) Indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components 8

9 Juluca (dolutegravir; rilpivirine) Formulation / Administration: Each tablet contains: 50mg of dolutegravir (equivalent to 52.6mg dolutegravir sodium) and 25mg of rilpivirine (equivalent to 27.5mg rilpivirine hydrochloride) One tablet taken orally once daily with a meal Rifabutin co-administration: Take an additional 25-mg tablet of rilpivirine with Juluca once daily with a meal for the duration of the rifabutin coadministration Juluca (dolutegravir; rilpivirine) Warnings/Precautions: Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a lifethreatening reaction Hepatotoxicity has been reported in patients receiving a dolutegravir-or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended Depressive disorders have been reported with the use of rilpivirine-or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms 9

10 Juluca (dolutegravir; rilpivirine) Drug Interactions: Because Juluca is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that induce or inhibit CYP3A4 or UGT1A1 may affect the plasma concentrations Drugs that increase gastric ph or containing polyvalent cations may decrease plasma concentrations Consider alternatives with drugs with a known risk of Torsade de Pointes Contraindicated with: Anticonvulsants, PPIs, St. John s wort (see table 1 and 4 for additional medications and explanation) Juluca (dolutegravir; rilpivirine) Dose adjustments: Renal impairment: In patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease, increased monitoring for adverse effect s is recommended Hepatic impairment: The effect of severe hepatic impairment (Child-P ugh Score C) on the pharmacokinetics of dolutegravir or rilpivirine is unknown 10

11 Other October FDA Approvals Lyrica CR (pregabalin) 1 10/11/2017: New Formulation: Extended release tablets (82.5mg, 165mg, and 330mg) Byurdeon Bcise (exanatide) 2 10/20/2017: New Dose Form: Extended-release injectable suspension Varubi (rolapitant) 3 10/25/2017: New Dosage Form: Injectable emulsion, for intravenous use Other October FDA Approvals Daptomycin 1 10/20/2017 New Formulation: 350 mg/vial for the treatment of adult patients with Complicated Skin and Skin Structure Infections (csssi) and Staphylococcus aureus Bloodstream Infections (Bacteremia), including those with Right-Sided Infective Endocarditis, caused by Methicillin- Susceptible and Methicillin-Resistant Isolates Calquence (acalabrutinib) 2 10/31/2017 New Molecular Entity: To treat adults with mantle cell lymphoma

12 Other October FDA Tentative Approvals Fosaprepitant 1-10/12/2017 New Formulation: 150mg/ml vial Pemfexy (pemetrexed) 2 10/26/2017 New Formulation: 25mg/ml vial Prexxartan (valsartan) 3 10/30/2017 New Dosage Form: Oral solution 4mg/ml Other November FDA Approvals Civanti (aprepitant) 1 11/9/2017: New Dosage Form: injectable emulsion; a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high- dose cisplatin Nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) Tekturna (aliskiren) 2 11/14/2017: New Dosage Form: oral pellets; renin inhibitor (RI) indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure

13 Other November FDA Approvals Hemlibra (emicizumab) 1 11/16/2017 To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors Mepsevii (vestronidase alfa-vjbk) 2 11/15/2017 To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome Thank you! 13