This year was another in which specialty pharmaceuticals featured prominently in the actions of the FDA.

Although there were not as many new specialty drug approvals to date in 2016, there were many already-approved specialty medications that received expanded indications. Below is the first installment of a summary of specialty pharmacy-related FDA approvals and expanded indications that took place in 2016.

The next installment, part II, will include oncology drugs, as well as late-breaking FDA actions. Please consult the product prescribing monographs for complete information including dosing regimens.

Bleeding Disorders
On March 4, 2016, the FDA approved Idelvion (coagulation factor IX [recombinant]), albumin fusion protein (rIX-FP), CSL Behring) in children and adults with hemophilia B (congenital factor IX deficiency) for on-demand control and prevention of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Idelvion is not indicated for immune tolerance induction in patients with hemophilia B. The drug is a recombinant coagulation factor IX protein with an extended half-life, developed through fusion with recombinant albumin for a longer duration of action. Idelvion is administered as an intravenous infusion. It is available as a lyophilized powder in single-use vials containing nominally 250, 500, 1000, or 2000 international units (IU) of factor IX activity per vial, packaged with sterile water for injection, USP for reconstitution, 1 Mix2Vial filter transfer set, and 1 sterile alcohol swab. Dosage and duration of treatment with Idelvion depends on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age, and recovery of factor IX.1,2

On March 17, 2016, Kovaltry (antihemophilic factor [recombinant]) was approved in adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes. Kovaltry is a recombinant, human DNA sequence derived, full length factor VIII concentrate.

Kovaltry is not indicated for the treatment of von Willebrand disease. Kovaltry is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU of recombinant factor VIII per vial. Dosage and duration of treatment depends on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.3,4

On May 25, 2016, Afstyla (antihemophilic factor [recombinant], Single Chain) was approved for adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding. Afstyla is not indicated for the treatment of von Willebrand disease.

Afstyla is available as a lyophilized powder in single-use vials containing nominally 250, 500, 1000, 2000, or 3000 IU. Dosage and duration of treatment depends on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.5,6

Inflammatory Conditions
On January 15, 2016, Cosentyx (secukinumab) received an expanded indication for the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Cosentyx was first approved on January 21, 2015, to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Cosentyx is a human interleukin-17A antagonist.

Cosentyx is available as a 150-mg/mL single-use Sensoready pen and single-use prefilled syringe. It is also available as a lyophilized powder in a single-use vial for reconstitution (for health care professional use only). Cosentyx is intended for use under the guidance and supervision of a physician; however, patients may self-inject using the pen or the prefilled syringe after proper training.

For PsA patients with coexistent moderate-to-severe plaque psoriasis, the dosing and administration recommendations for plaque psoriasis should be used. The recommended dose for plaque psoriasis is 300 mg by subcutaneous injection at weeks 0,1,2,3, and 4 followed by 300 mg every 4 weeks. For some plaque psoriasis patients, a dose of 150 mg may be sufficient. For other PsA patients and AS patients, Cosentyx can be administered with or without a loading dose by subcutaneous injection.

The recommended dosage with a loading dose is 150 mg at weeks 0, 1, 2, 3, 4, and then every 4 weeks thereafter; and without a loading dose is 150 mg every 4 weeks. For PsA patients, if they continue to have active PsA a dosage of 300 mg can be considered. 7,8

On February 24, 2016, the FDA approved a new extended release dosage form of Xeljanz called XeljanzXR (tofacitinib). XeljanzXR was approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who had inadequate response or intolerance to methotrexate.

XeljanzXR may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs. Xeljanz was originally approved in November 2012. XeljanzXR is an inhibitor of Janus Kinases. XeljanzXR is available in an 11 mg tablet, and the recommended dose is 1 tablet orally once daily. The use of XeljanzXR is not recommended in patients with severe hepatic impairment.9,10

On March 22, 2016, Taltz (ixekizumab) was approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is a humanized interleukin-17A antagonist.

Taltz is available as a subcutaneous injection in a prefilled auto-injector or a single-dose prefilled syringe containing 80 mg/mL. The recommended starting dose for Taltz is 160 mg (two 80-mg subcutaneous injections) at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.11,12

On April 5, 2016, Inflectra (infliximab-dyyb) was approved as a biosimilar to Janssen Biotech’s Remicade (infliximab) for multiple indications. Inflectra is a tumor necrosis factor (TNF) blocker indicated for treatment of adults with Crohn’s Disease; ulcerative colitis; and RA in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis; and for pediatric Crohn’s Disease.

Inflectra is to be administered by IV infusion over a period of no less than 2 hours. The recommended dosage for patients with Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, PsA, and plaque psoriasis is 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. The recommended dosage in patients with rheumatoid arthritis is 3mg/kg at 0, 2, and 6 weeks, then every 8 weeks in conjunction with methotrexate.

In patients with ankylosing spondylitis, the recommended dosage is 5 mg/kg at 0, 2, and 6 weeks, then every 6 weeks. Inflectra is available in single-use vials containing 100 mg of infliximab-dyyb for final reconstitution to a volume of 10 mL.13,14

On June 30, 2016, Humira (adalimumab) received an expanded indication for the treatment of noninfectious intermediate, posterior, and panuveitis in adult patients. This now marks the tenth approved indication of Humira for immune-mediated diseases. Humira was originally approved on December 31, 2002, for the treatment of RA and has since received indications for Juvenile Idiopathic Arthritis (JLA), PsA, ankylosing spondylitis, adult and pediatric (6 years and older) Crohn’s disease, adult ulcerative colitis, plaque psoriasis, and moderate-to-severe hidradenitis suppurativa .

Humira is available as a subcutaneous injection in a prefilled glass syringe containing 10 mg/0.2mL, 20 mg/0.4mL, 40 mg/0.4mL, 40 mg/0.8mL, or 80 mg/0.8mL. It is also available in a 40-mg/0.4mL and 40-mg/0.8mL single-use prefilled pen and in a 40-mg/0.8mL single-use glass vial for institutional use only. The recommended starting dose for uveitis is 80 mg initially, followed by 40 mg every other week starting 1 week after initial dose.15,16

On August 30, 2016, Erelzi (etanercept-szzs) was approved as a biosimilar to Amgen’s Enbrel (etanercept) for multiple inflammatory diseases. Erelzi is a TNF blocker indicated for the treatment of RA, polyarticular JLA in patients age 2 or older, PsA, ankylosing spondylitis, and plaque psoriasis. Erelzi is to be administered as a subcutaneous injection.

The recommended dosage of Erelzi is dependent upon indication. The drug is available in a single-dose prefilled syringe containing either 25-mg/0.5mL or 50-mg/mL solution, and in a single-dose prefilled SensoreadyPen containing 50-mg/1mL solution.17,18

On September 23, 2016, Amjevita (adalimumab-atto) was approved as a biosimilar to Humira (adalimumab) for several inflammatory diseases. Amjevita has been approved for RA, PsA, and JIA in patients age 4 years or older, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. Amjevita is to be administered by subcutaneous injection.

The recommended dosage is dependent upon the patient’s indication. Amjevita is available in a single-dose prefilled syringe containing either 20-mg/0.4mL or 40-mg/0.8mL solution, and in a 40-mg/0.8mL single-dose prefilled SureClick autoinjector.19,20

On September 23, 2016, Ilaris (canakinumab) added 3 new indications when the FDA approved its use for the treatment of rare and serious auto-inflammatory diseases in adult and pediatric patients who have tumor necrosis factor receptor associated periodic syndrome (TRAPS); hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD); or familial Mediterranean fever (FMF); active systemic JIA (SJIA) in patients age 2 years and older.

Ilaris was initially approved in 2009 for the treatment of cryopyrin-associated periodic syndromes (CAPS) in patients age 4 and older, and was subsequently approved for SJIA in patients age 2 and older. Ilaris is an interleukin-1 beta inhibitor available in 150-mg single-dose lyophilized powder vials for reconstitution. Dosing is dependent upon indication and body weight.21,22

On September 26, 2016, Stelara (ustekinumab) was granted an additional indication for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who failed, or were intolerant to, treatment with immunomodulators or corticosteroids, but never failed treatment with a TNF blocker, or who failed or were intolerant to treatment with 1 or more TNF blockers.

The initial intravenous dosage for Crohn’s disease is based on the patient’s weight. After the initial intravenous dose, the maintenance dose for Crohn’s disease is 90-mg subcutaneously 8 weeks after the initial intravenous dose, then every 8 weeks thereafter. It is a human interleukin-12 and interleukin-23 antagonist previously approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and either alone or in combination with methotrexate to treat patients with active PsA.

Stelara is available in a 45-mg/0.5 mL or 90-mg/mL single-dose prefilled syringe or 45-mg/0.5 mL in a single-dose vial for subcutaneous injection and as a 130-mg/26 mL (5-mg/mL) solution in a single-dose vial for intravenous infusion.23,24

HIV
On March 1, 2016, Odefsey (emtricitabine [FTC]/rilpivirine/tenofovir alafenamide [TAF]) was approved as a complete regimen for the treatment of HIV-1 infection in patients age 12 and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in patients virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure, and no known substitutions associated with resistance to the individual components of the drug.

Odefsey is a 3-drug combination tablet of FTC 200-mg and TAF 25-mg, both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and RPV 25-mg, a non-nucleoside reverse transcriptase inhibitor. The recommended dosage of Odefsey is one tablet orally once daily with a meal.25,26

On April 4, 2016, Descovy (FTC and TAF) was approved for the treatment of adults and pediatric patients age 12 years and older with HIV-1 infection in combination with other antiretroviral agents. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. Descovy is a fixed-dose combination containing 200-mg of FTC and 25-mg TAF, both HIV nucleoside NRTIs. The recommended dosage is 1 tablet taken once daily with or without food.27,28

On July 18, 2016, Prezista (darunavir) received an expanded indication for use in pregnant women with HIV. Prezista is an HIV-1 protease inhibitor originally approved in 2006 for HIV-1 infection in adult and pediatric patients age 3 and older. Prezista must be co-administered with ritonavir and with other antiretroviral agents. Prezista is available in an oral suspension, 100 mg/mL, and tablet strengths of 75 mg,150 mg, 600 mg, and 800 mg. The recommended dosage for pregnant patients is 600 mg taken with ritonavir 100 mg twice daily with food.29,30

Hepatitis C
On January 28, 2016, Zepatier (elbasvir and grazoprevir) was approved for treatment of chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in adults with or without ribavirin. Zepatier is a fixed-dose combination tablet containing 50 mg elbasvir (an HCV NS5A inhibitor) and 100 mg grazoprevir (an HCV NS3/4A protease inhibitor). The recommended dosage is 1 tablet taken orally once daily with or without food. The duration of therapy and co-administration of ribavirin is dependent upon HCV genotype, whether or not the patient is treatment experienced, and whether or not the patient has cirrhosis.31,32

On February 5, 2016, the FDA approved changes to the Daklinza (daclatasvir) label to expand the indication to include HCV genotype 1 infection; to revise dosage recommendations for HCV genotype 3 patients with compensated (Child-Pugh A) cirrhosis; and to expand dosage recommendations to the following populations: HCV genotype 1 and 3 patients coinfected with HIV-1; HCV genotype 1 and 3 posttransplant patients; HCV genotype 1 patients with compensated (Child-Pugh A) cirrhosis and decompensated (Child-Pugh B or C) cirrhosis; and HCV genotype 3 patients with decompensated (Child-Pugh B or C) cirrhosis.

Daklinza was initially approved in July 2015 by the FDA for use in adult patients in combination with Sovaldi (sofosbuvir) to treat HCV genotype 3 infections. Daklinza is available in a 60-mg and 30-mg tablet. The recommended dosage of Daklinza is 60 mg taken orally once daily in combination with sofosbuvir with or without ribavirin for 12 weeks. Daklinza may be taken with or without food. If sofosbuvir is permanently discontinued in a patient receiving Daklinza with sofosbuvir, then Daklinza should also be discontinued.33,34

On February 16, 2016, Harvoni (ledipasvir and sofosbuvir) received an expanded approval for 2 supplemental indications in chronic HCV patients with advanced liver disease. Harvoni in combination with ribavirin for 12 weeks was approved for use in HCV genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A); and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. 

Harvoni, first approved in October 2014, is now indicated for the treatment of HCV genotype 1, 4, 5 or 6 infections with or without ribavirin. Harvoni contains 90 mg of ledipasvir (an HCV NS5A inhibitor) and 400 mg of sofosbuvir (an HCV nucleotide analog NS5B polymerase inhibitor) in a single tablet. The recommended dosage of Harvoni is 1 tablet taken orally once daily, with or without food, and the duration of treatment depends on the genotype, if the patient is treatment naïve or treatment experienced, and if patient is with or without cirrhosis. Harvoni contains sofosbuvir, which is the active agent in Sovaldi, originally approved by the FDA in December 2013.35,36

On June 28, 2016, Epclusa (sofosbuvir and velpatasvir) was approved as a single agent for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infections in adult patients with or without compensated cirrhosis. In patients with decompensated cirrhosis, Epclusa can be used in combination with ribavirin. Epclusa is a fixed-dose combination of sofosbuvir (an HCV nucleotide analog NS5B polymerase inhibitor) and velpatasvir (an HCV NS5A inhibitor).

Epclusa is available in a tablet formulation containing 400 mg of sofosbuvir and 100 mg of velpatasvir. The recommended dosage is 1 tablet taken orally once daily with or without food. For patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A), the duration of therapy is 12 weeks and for patients with decompensated cirrhosis (Child-Pugh B or C), the duration of therapy for Epclusa plus ribavirin is 12 weeks.37,38

On July 22, 2016, Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets were approved by the FDA for the treatment of adult patients with chronic HCV who have genotype 1b infection without cirrhosis or with compensated cirrhosis, and genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Viekira XR is not for patients with decompensated cirrhosis. Viekira XR consists of 200 mg of dasabuvir (an HCV nonnucleoside NS5B palm polymerase inhibitor), 8.33 mg of ombitasvir, (an HCV NS5A inhibitor), 50 mg of paritaprevir (an HCV NS3/4A protease inhibitor), and 33.33mg of ritonavir (a CYP3A inhibitor). Viekira XR is given once-daily as 3 oral tablets, and must be taken with a meal. The duration of therapy can range anywhere from 12 to 24 weeks, with or without ribavirin, depending upon the genotype and course of cirrhotic status.39,40

Asthma
On March 23, 2016, Cinqair (reslizumab) was approved as an add-on maintenance treatment for patients with severe asthma age 18 years and older with an eosinophilic phenotype. Cinqair is not indicated for treatment of other eosinophilic conditions and is not indicated for relief of acute bronchospasm or status asthmaticus. Cinqair is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa).

It is available in single-use vials containing 100-mg/10mL (10mg/mL) solution. The recommended dosage regimen for Cinqair is 3 mg/kg once every 4 weeks by intravenous infusion over 20 to 50 minutes in a health care setting by a professional prepared to manage anaphylaxis.41,42

On July 7, 2016, Xolair (omalizumab) received an expanded indication to treat moderate-to-severe persistent asthma in children 6- to 11-years-old who have had a positive skin test or in vitro reactivity to an airborne allergen, and who have symptoms that are inadequately controlled with inhaled corticosteroids. Xolair was previously approved to treat people age 12 and older with allergic asthma, as well as chronic idiopathic urticaria (CIU) in adults and adolescents age 12 and older who remain symptomatic despite H1 antihistamine treatment.

Xolair, an anti-IgE antibody, is available as a subcutaneous injection administered by a provider in a health care setting. For patients with asthma, the recommended dose is 75- to 375-mg subcutaneously every 2 or 4 weeks.43,44

Miscellaneous Specialty Approvals
On March 18, 2016, Anthim (obiltoxaximab) was approved in adult and pediatric patients for treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

Anthim is a monoclonal antibody directed against the protective antigen of B. anthracis. Anthim is available as a 600-mg/6mL (100-mg/mL) solution for intravenous injection in a single-dose vial. The recommended dosage of Anthim in adult patients is a single dose of 16 mg/kg. Dosing varies in pediatric patients based on weight.

Anthim should be diluted in 0.9% sodium chloride injection, USP, before administering as an IV infusion over 1 hour and 30 minutes. Patients should receive the dose in a monitored setting equipped to manage anaphylaxis.45,46

On May 27, 2016, Ocaliva (obeticholic acid) was approved for the treatment of primary biliary cholangitis (previously known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. This indication is considered an accelerated approval based on a reduction in alkaline phosphatase.

An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Ocaliva is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine, and a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways.

Ocaliva is available in a 5-mg and 10-mg tablet to be taken with or without food. The recommended starting dosage of Ocaliva is 5 mg orally once-daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year, or are intolerant to UDCA. If adequate reduction in alkaline phosphatase and/or total bilirubin has not been achieved after 3 months of Ocaliva 5 mg once-daily and the patient is tolerating Ocaliva, the dose can be increased to a maximum of 10 mg once-daily.47,48

On May 27, 2016, the FDA approved Zinbryta (daclizumab), an interleukin-2 receptor blocking antibody, for the treatment of adult patients with relapsing forms of multiple sclerosis who had an inadequate response to 2 or more drugs. Due to the serious safety risks associated with Zinbryta, such as risk of hepatic injury and immune meditated disorders, it is only available through a restricted distribution program called the Zinbryta REMS Program. Zinbryta is available in a 150-mg/mL solution in a single-dose prefilled syringe to be injected subcutaneously once monthly.49,50

On July 11, 2016, Repatha (evolocumab) was approved in a monthly single-dose formulation, the Repatha Pushtronex system (on-body infusor with prefilled cartridge). The Pushtronex system is a hands-free device designed to provide 420-mg of Repatha in a single dose. Repatha was originally approved on August 27, 2015, as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, in patients who require additional lowering of low density lipoprotein cholesterol (LDL-C).

Repatha is also indicated as an adjunct to diet and other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined. Repatha is available as a single-use 140-mg prefilled SureClick autoinjector or prefilled syringe, and a 420-mg/3.5 mL solution in a single-use Pushtronex system for subcutaneous use that patients can self-administer.51,52

On September 14, 2016, the FDA approved Cuvitru (immune globulin subcutaneous [human] 20% solution) as a replacement therapy for primary humoral immunodeficiency in adult and pediatric patients age 2 and older. Cuvitru is available as a subcutaneous infusion administered at regular intervals, ranging from daily up to biweekly, with the dosing regimen individualized based upon on the patient’s pharmacokinetic and clinical response.

Cuvitru may be infused into a maximum of 4 sites simultaneously, facilitated with a multi-needle administration set. Cuvitru is supplied in single-use vials containing 200-mg/mL (20%) protein solution in a 5-mL, 10-mL, 20-mL and 40-mL vial.53,54

On September 28, 2016, the FDA expanded the age range of the indication for Orkambi (lumacaftor/ivacaftor) to include patients age 6 and older. Orkambi is a combination of lumacaftor and ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, indicated for the treatment of cystic fibrosis (CF) in patients age 6 and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. Orkambi is available in 2 strengths: lumacaftor 100 mg/ivacaftor 125 mg; and lumacaftor 200 mg/ivacaftor 125 mg.

The recommended dosage in adults and pediatric patients, age 12 and older, is 2 tablets (each containing lumacaftor 200 mg/ivacaftor 125 mg) taken orally every 12 hours with fat-containing foods. The recommended dose for pediatric patients age 6 through 11 years is 2 tablets (each containing lumacaftor 100 mg/ivacaftor 125 mg) orally every 12 hours. The dose should be adjusted for patients with hepatic impairment and taking CYP3A inhibitors.55,56

On October 14, 2016, the FDA granted Lucentis (ranibizumab) an approval for a 0.5-mg prefilled syringe. Lucentis is a vascular endothelial growth factor inhibitor. Lucentis is approved for neovascular (wet) age-related macular degeneration; for macular edema following retinal vein occlusion; for diabetic macular edema (DME); and for the treatment of diabetic retinopathy in patients with DME.

Lucentis is also available in 2 dosage strengths in single-use glass vials designed to provide 0.05 ml for intravitreal injection: 10-mg/ml (Lucentis 0.5-mg) and 6-mg/ml (Lucentis 0.3-mg). The recommended dosage of Lucentis is dependent upon the indication.57,58 

References 
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  24. Stelara Prescribing Information, Janssen Biotech, Inc., September 2016. Available at: https://www.stelarainfo.com/pdf/prescribinginformation.pdf Accessed: October 31, 2016.
  25. Odefsey Prescribing Information, Gilead Sciences, Inc., March 2016. Available at: https://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pdf?la=en Accessed: April 1, 2016.
  26. U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection, Gilead Sciences, Inc., March 1, 2016. Available at: http://www.gilead.com/news/press-releases/2016/3/us-food-and-drug-administration-approves-gileads-second-tafbased-single-tablet-regimen-iOdefsey-emtricitabine-rilpivirine-tenofovir-alafenamide-for-the-treatment-of-hiv1-infection Accessed: April 1, 2016.
  27. Descovy Prescribing Information, Gilead Sciences Inc., April 2016. Available at: http://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en Accessed: May 2, 2016.
  28. U.S. Food and Drug Administration Approves Descovy (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV, Gilead Sciences, Inc., April 4, 2016. Available at: http://www.gilead.com/news/press-releases/2016/4/us-food-and-drug-administration-approves-descovy-emtricitabine-tenofovir-alafenamide-gileads-third-tafbased-hiv-therapy Accessed: May 2, 2016.
  29. Prezista Prescribing Information, Janssen Pharmaceuticals, Inc., July 2016. Available at: http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf#zoom=100 Accessed: August 19, 2016
  30. Janssen Therapeutics Release: U.S. FDA Approves PREZISTA (Darunavir) For Use In Pregnant Women With HIV, Janssen Pharmaceuticals, Inc., July 18, 2016. Available at: http://www.biospace.com/news_story.aspx?StoryID=426349&full=1 Accessed: August 19, 2016.
  31. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4, US FDA, January 28, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm Accessed: March 29, 2016.
  32. Zepatier Prescribing Information, Merck&Co., Inc., January 2016. Available at: http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf Accessed: March 29, 2016.
  33. FDA Hepatitis Update - Changes to the Daklinza (daclatasvir) label expand indication, US FDA, February 5, 2016, Available at: https://content.govdelivery.com/accounts/USFDA/bulletins/134cc5e Accessed: March 29, 2016.
  34. Daklinza Prescribing Information, Bristol-Myers Squibb, March 2016. Available at: http://packageinserts.bms.com/pi/pi_daklinza.pdf Accessed: March 29, 2016.
  35. HarvoniTM Prescribing Information. Gilead Sciences, February 2016 . Available at: http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf Accessed: March 31, 2016
  36. U.S. FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients with Advanced Liver Disease, Gilead Sciences, February 16, 2016. Available at: https://www.gilead.com/news/press-releases/2016/2/us-fda-approves-two-supplemental-indications-for-harvoni-in-chronic-hepatitis-c-patients-with-advanced-liver-disease Accessed: March 31, 2016
  37. Epclusa Prescribing Information, Gilead Sciences, Inc. June 2016. Available at: https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf?la=en Accessed: August 17, 2016.
  38. FDA approves Epclusa for treatment of chronic Hepatitis C virus infection, US FDA, June 28, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm Accessed: August 17, 2016.
  39. Viekira XR Prescribing Information, Abbvie, Inc., July 2016. Available at: http://www.rxabbvie.com/pdf/viekiraxr_pi.pdf Accessed: July 2016
  40. AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C, Abbvie Inc., July 25, 2016. Available at: https://news.abbvie.com/news/abbvie-receives-us-fda-approval-once-daily-viekira-xr-dasabuvir-ombitasvir-paritaprevir-and-ritonavir-for-treatment-genotype-1-chronic-hepatitis-c.htm Accessed: July 31, 2016.
  41. Cinqair Prescribing Information, Teva Pharmaceutical Industries Ltd., March 2016. Available at: http://www.cinqair.com/ Accessed: April 4, 2016.
  42. FDA approves Cinqair to treat severe asthma, US FDA, March 23, 2016. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm491980.htm Accessed: April 4, 2016.
  43. Xolair Prescrbing Information, Genetech and Novartis, July 2016. Available at: http://www.gene.com/download/pdf/xolair_prescribing.pdf Accessed: August 19, 2016.
  44. Novartis announces FDA approval of Xolair (omalizumab) for pediatric allergic asthma, Novartis, July 7, 2016. Available at: https://www.pharma.us.novartis.com/news/media-releases/novartis-announces-fda-approval-xolairr-omalizumab-pediatric-allergic-asthma Accessed: August 19, 2016.
  45. Anthim Prescribing Information, Elusys Therapeutics, Inc., March 2016. Available at: http://www.anthim.com/download/pdf/ANTHIM-prescribing-information.pdf Accessed: April 4, 2016.
  46. FDA approves new treatment for inhalation anthrax, US FDA, March 18, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491470.htm Accessed; April 4, 2016.
  47. Ocaliva Prescribing Information, Intercept Pharmaceuticals, Inc., May 2016. Available at: https://ocaliva.com/ocaliva_pi.pdf Accessed: August 17, 2016
  48. FDA approves Ocaliva for rare, chronic liver disease, US FDA, May 31, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503964.htm Accessed: August 17, 2016.
  49. Zinbryta Prescribing Information, Abbvie, Inc. and Biogen, May 2016. Available at: https://www.zinbryta.com/content/dam/commercial/multiple-sclerosis/zinbryta/pat/en_us/pdfs/zinbryta-prescribing-information.pdf Accessed: August 17, 2016.
  50. FDA approves ZinbrytaTM to treat multiple sclerosis, US FDA, May 27, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504000.htm Accessed: August 17, 2016.
  51. Repatha Prescribing Information, Amgen, July 2016. Available at: http://pi.amgen.com/united_states/repatha/repatha_pi_hcp_english.pdf Accessed: October 31, 2016.
  52. FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor, Amgen, July 11, 2016. Available at: http://www.amgen.com/media/news-releases/2016/07/fda-approves-first-and-only-single-monthly-injection-for-a-pcsk9-inhibitor/ Accessed: October 31, 2016.
  53. Shire Announces U.S. FDA Approval of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Treatment for Primary Immunodeficiency, Shire pic, September 14, 2016. Available at: http://www.prnewswire.com/news-releases/shire-announces-us-fda-approval-of-cuvitrutm-immune-globulin-subcutaneous-human-20-solution-treatment-for-primary-immunodeficiency-593374251.html Accessed: October 31, 2016.
  54. Cuvitru Prescribing Information, Shire pic, September 2016. Available at: http://www.shirecontent.com/PI/PDFS/Cuvitru_USA_ENG.PDF Accessed: October 31, 2016.
  55. Orkambi Prescribing Information, Vertex Pharmaceuticals, September 2016. Available at: http://pi.vrtx.com/files/uspi_lumacaftor_ivacaftor.pdf Accessed: October 31, 2016. '
  56. U.S. Food and Drug Administration Approves ORKAMBI (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation, Vertex Pharmaceuticals, September 28, 2016. Available at: http://investors.vrtx.com/releasedetail.cfm?ReleaseID=991350 Accessed: October 31, 2016.
  57. FDA Approves Genentech’s Lucentis (Ranibizumab Injection) Prefilled Syringe, Genentech, October 14, 2016. Available at: http://www.businesswire.com/news/home/20161014005672/en/FDA-Approves-Genentech%E2%80%99s-Lucentis%C2%AE-Ranibizumab-Injection-Prefilled Accessed: October 31, 2016.
  58. Lucentis Prescribing Information, Genentech, October 2016. Available at: https://www.gene.com/download/pdf/lucentis_prescribing.pdf Accessed: October 31, 2016.



About the Author
Stacey Ness, Pharm D, RPh, CSP, MSCS, AAHIVP
, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence, and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, National Association of Specialty Pharmacy, Specialty Pharmacy Certification Board, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a certified multiple sclerosis specialist, a credentialed HIV pharmacist, a Certified Specialty Pharmacist, and currently serves as the senior director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, New Jersey.

Ruby Mhajan, RPh, currently serves as a clinical pharmacist at Managed Health Care Associates, Inc., a health care services organization based in Florham Park, New Jersey. Ruby has over 13 years of experience as a clinical pharmacist, having worked in both the United States and Canada in various settings including retail, long-term care, home infusion/specialty, and a national outsourcing admixture pharmacy. Most recently, she served as a Director of Pharmacy for a Home Infusion/Specialty Pharmacy in New York.