FDA Approved Drugs: September 2020
Monjuvi Approved for Second-Line Treatment of Diffuse Large B-Cell Lymphoma
MorphoSys received approval from the FDA on July 31, 2020, for Monjuvi® (tafasitamab-cxix) for injection. It is a CD19-directed monoclonal antibody that is approved for use with Revlimid® (lenalidomide – Celgene) capsules for treating patients whose diffuse large B-cell lymphoma (DLBCL) has returned or has stopped responding to prior treatment and who are not candidates for stem cell transplants. To treat DLBCL, Monjuvi will be administered at 12mg/kg by intravenous (IV) infusion on 28-day cycles. For the first cycle, infusions will be given on the first, fourth, eighth, fifteenth and twenty-second days. Then, infusions will be administered on days one, eight, 15 and 22 for the next two cycles. On all successive cycles, Monjuvi will be infused on only the first and fifteenth days. Revlimid is stopped following 12 cycles, but Monjuvi continues until the cancer recurs or the patient cannot tolerate the drug’s side effects. MorphoSys and Incyte will market Monjuvi jointly in the U.S. They anticipate a launch as soon as this week at an estimated wholesale acquisition cost (WAC) of $198,000 for the first year of treatment for a patient weighing approximately 75kg (about 165 pounds). After the first three cycles, monthly WAC will be about $13,000. Monjuvi’s approval was granted under the FDA’s Accelerated Approval, Breakthrough Therapy and Fast Track pathways. For its prescribing information, please look here.
Second Indication for Spravato
On July 31, the FDA granted an additional indication to Janssen’s Spravato® (esketamine) nasal spray. In combination with an oral antidepressant, it now is approved to treat adult patients who have major depression and who have expressed suicidal thoughts or exhibited suicidal actions. In clinical studies, symptoms of depression began to decrease within four hours for some participants treated with the combination of drugs. Spravato originally was FDA approved in March 2019, along with an oral antidepressant, for adults who have depression that is not managed by other antidepressants. It is a C-III controlled substance intended to be distributed under a risk evaluation and mitigation strategy (REMS) directly to certified treatment centers that have specially trained providers. Although patients administer their own doses of Spravato, they are supervised during each treatment and then their blood pressure is monitored for a minimum of two hours afterward. A boxed warning, the REMS and a patient Medication Guide caution that Spravato is sedating, that it may cause changes in perception and that it may be abused. Using it actually may cause suicidal feelings for some patients, as well. Recommended dosing for the new indication is 56mg (four sprays) on the first day, then either 56mg or 84mg (six sprays) two times a week for the rest of a four week period. If the patient is responding, Spravato can be continued at 56mg or 84mg once a week for four more weeks and then at 56mg or 84mg once a week or once every two weeks – whichever is the lowest dose and least frequent timing to maintain relief of depression. Treatment beyond 4 weeks has not been systematically evaluated for Spravato for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior. For complete prescribing information, please look here.
Epidiolex Receives New Indication
The FDA approved Epidiolex® (cannabidiol – GW Pharmaceuticals) on July 31, 2020, to treat patients who are at least one year old for seizures caused by tuberous sclerosis complex (TSC). At the same time, the previous Epidiolex indications to treat seizures associated with Dravet syndrome (DS) or Lennox-Gestaut syndrome (LGS) also were extended to children as young as one year old. Even though all three conditions are rare, TSC affects about 50,000 patients in the U.S. It causes non-cancerous tumors in body organs, including in the brain. TSC can produce different types of seizures at varying degrees of severity. Pediatric patients who have it also may be on the autism spectrum, have attention deficit hyperactivity disorder (ADHD) and/or suffer from intellectual disabilities. Adults who have TSC are more likely to be anxious or depressed than individuals who do not have the condition. More than one-half of patients eventually have seizures that cannot be controlled by currently available anticonvulsant drugs. To treat TSC, the recommended initial dose of Epidiolex is 2.5mg/kg twice each day for one week, then increased by 2.5mg per dose on a weekly basis until reaching the maintenance dose of 12.5mg/kg twice daily. Here is its full prescribing information.
Blenrep Approved to Treat Multiple Myeloma
The first drug in a new class called B-cell maturation antigen (anti-BCMA) agents, GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) was approved by the FDA) on Aug. 5, 2020. An antibody-drug conjugate, it is indicated as monotherapy for relapsed or refractory multiple myeloma after four or more previous treatments that include an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. Belantamab, the antibody part of Blenrep, is specifically attracted to BCMA, a substance that is expressed by plasma cells affected by multiple myeloma. Once the conjugate sticks to cancer cells, mafodotin, a microtubule inhibitor, enters the cancer cells and prevents them from dividing. Recommended dosing is as a 30-minute IV infusion of 2.5mg/kg once every three weeks. Launch is planned during August. A risk evaluation and evaluation strategy (REMS), due to possibly severe effects that Blenrep may have on vision, will limit its use to specially trained healthcare providers. Patients will receive education on its possible risks, as well. Monthly wholesale acquisition cost (WAC) is estimated to average $23,900, depending on the patient’s weight. Blenrep was approved under the FDA’s Accelerated Approval and Breakthrough Therapy programs. Here is complete prescribing information for Blenrep.
FDA Approves Lampit for Chagas Disease
Bayer’s Lampit® (nifurtimox) tablets was granted Accelerated Approval by the FDA on Aug. 6, 2020. It is an antiprotozoal drug indicated to treat children up to the age of 18 years for Chagas disease. The Centers for Disease Control and Prevention (CDC) estimates that approximately 300,000 Americans have Chagas disease, which progresses in two phases. The acute phase has only general symptoms that are similar to the flu and that last for a few weeks after exposure. Infection is confirmed with a blood test for antibodies to the Trypanosoma cruzi parasite, which is transmitted to humans and animals primarily through contact with triatomine bugs. Also called kissing bugs because they bite sleeping people on the thinner skin around the mouth and eyes, triatomine bugs carry T. cruzi. Fairly prevalent in Central and South America, triatomine bugs are becoming more common in warm weather areas of the United States, as well. If untreated, an acute Chagas disease infection may become chronic. Usually asymptomatic, chronic Chagas disease lasts for decades and eventually results in serious heart and digestive system problems for 30% or more of individuals who have it. To treat it, Lampit will be dosed by weight and given three times a day for 60 days. The 30mg and 120mg tablets are designed to be cut easily into fractional pieces and they can be mixed with a small amount (less than one teaspoonful) of water and given to children who cannot swallow tablets. Lampit will compete with benznidazole, an antiprotozoal drug that the FDA approved in August 2017 to threat Chagas disease for children between the ages of two years and 12 years of age. No pricing or launch plans have been announced for Lampit. Its prescribing information is here.
Dovato Indication Expanded
First FDA approved in April 2019 as therapy for previously untreated adult patients who have HIV-1 infection, ViiV Healthcare’s Dovato (dolutegravir 50mg/lamivudine 300mg) tablets received an additional approval on Aug. 6, 2020, for patients who have been using other HIV treatments. Dovato is not intended for patients whose treatment has failed to control HIV-1 virus levels. To switch from another regimen, viral loads will have to be consistently lower than 50 copies of HIV-1 RNA/mL of blood, and the patient must not have become resistant to either component of Dovato. It combines an integrase strand transfer inhibitor and a nucleoside reverse transcriptase inhibitor without the need for a third drug to be a complete HIV-treatment regimen. Labeling for it has a boxed warning that taking lamivudine or stopping it may induce hepatitis B (hep B) flares for patients who have both HIV and hep B. Additionally, hep B may develop resistance to treatment with lamivudine. All patients should be tested for hep B before starting treatment with Dovato. Complete prescribing information may be found here.
Evrysdi Approved for Spinal Muscular Atrophy
The FDA approved Genentech’s Evrysdi™(risdiplam) on Aug. 7, 2020 – slightly ahead of its scheduled action date. It is in a new class of drugs – survivor of motor neuron 2 (SMN2) splicing modifiers. Approved for patients two months of age and older, it treats spinal muscular atrophy (SMA) that is due to SMN protein deficiency resulting from mutations in chromosome 5q. SMA is a rare genetic condition that causes increasing weakness in muscles. Evrysdi stimulates the SMN2 gene to make more functioning proteins. To treat SMA, Evrysdi will be given as an oral solution once daily at a dose of 0.2mg/kg for children two months to less than two years of age, 0.25mg/kg for children two years of age and older weighing less than 20kg or 5mg for patients two years of age and older weighing 20kg or more. Based on wholesale acquisition cost (WAC), the annual cost of therapy for a patient weighing 20kg or more is $340,000. For patients weighing less than 20kg, the cost varies based on the patient’s age and weight. For example, for a child younger than 2 years old weighing 15 pounds (7kg), the annual cost of therapy would be less than $100,000. Launch is planned within two weeks in collaboration with PTC Therapeutics. Two other treatments, a gene therapy, Zolgensma® (onasemnogene abeparvovec-xioi – AveXis) and a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide, Spinraza™ (nusinersen – Ionis Pharmaceuticals/ Biogen), are FDA approved to treat certain patients with SMA. Zolgensma is given as a one-time IV infusion. Spinraza is administered as an intrathecal injection (into the fluid around the spinal cord) once every four months. Evrysdi, which has been designated as an Orphan Drug, was approved under the FDA’s Fast Track and Priority Review pathways. Additionally, it qualified for a Rare Pediatric Disease Priority Review Voucher, which can be used to accelerate approval of a future FDA submission. Here is prescribing information.
First Generic Available for Ciprodex
Dr. Reddy’s Laboratories released ciprofloxacin 0.3%/dexamethasone 0.1%, a generic for Bayer’s Ciprodex® Otic Suspension, to the U.S. market as soon as it was FDA approved on Aug. 10, 2020. It contains an antibiotic and a corticosteroid to treat infections in the middle ear (acute otitis media) and the outer ear canal (acute otitis externa). Directions are to use four drops in the affected ear twice a day until the infection is gone. If the ear is still painful and/or inflamed after being treated for one week, therapy should be re-evaluated with the prescriber. Patients or their caregivers should be careful not to touch the tip of the applicator bottle to the ear surface or with their hands. Pricing is not immediately available. According to IQVIA, sales of the brand product amounted to about $453 million in the U.S. during the 12-month period that ended on June 30, 2020.
MedWatch Update: Hand Sanitizers
A previous FDA warning about hand sanitizers labeled as being ethanol, but actually containing methanol has been extended to include products that are another type of alcohol, 1-propanol. Neither methanol nor 1-propanol is approved by the FDA for use in the U.S. They can be dangerous if swallowed -- potentially leading to breathing problems, confusion, loss of consciousness and other adverse effects, including death. In contact with the skin or eyes, 1-propanol may be irritating. Individuals who may have been exposed to a contaminated hand sanitizer should check the FDA’s revised list of unsafe products for the brand name of the product they use. If it is on the list, they should stop using the product, dispose of sealed bottles in a hazardous waste container and contact a healthcare provider if they have symptoms. The sanitizers should not be poured down the drain. The FDA has stopped imports of contaminated hand sanitizers and their manufacturers have been warned not to continue making them. The updated FDA notice is here.
Additionally, the FDA is informing consumers of hand sanitizer products that are being sold in packages that resemble beverage cans, fruit juice boxes, water bottles and other containers mostly associated with foods or drinks. Some products also may be scented with food flavors, such as chocolate, or labeled in ways that draw the attention of children. Drinking just a small amount of any form of hand sanitizer can be seriously harmful to a small child and consuming one of the non-ethanol products can cause severe heart and/or brain damage for individuals of any age. Shoppers are advised to read labels carefully to be sure they are not mistaking a hand sanitizer for a food or drink. For more information, check here and here.
Viltepso Approved for Duchenne Muscular Dystrophy
On Aug. 12, 2020, the FDA approved NS Pharma’s Viltepso™ (viltolarsen) for the treatment of Duchenne muscular dystrophy (DMD) for patients who have a confirmed mutation amenable to exon 53 skipping. DMD is a rare genetic disease that affects around 10,000 boys and young men in the United States. In DMD, a mutation in the gene for dystrophin, a muscle protein, causes progressive muscle wasting. Eventually, DMD patients need to use wheelchairs and ventilators. Currently, few patients live beyond 30 years of age. About 8% of patients with DMD have a confirmed mutation amenable to exon 53 skipping. Exons are bits of DNA or RNA that contain the information needed to produce specific proteins. Viltepso, an antisense oligonucleotide that works by “skipping” over exon 53 to result in shorter, but partially functioning dystrophin, is given as a once-weekly IV infusion at a dose of 80mg/kg of body weight. NS Pharma has not yet announced when it intends to launch Viltepso. In addition, pricing information and distribution plans are unknown at this time. In addition to receiving Accelerated Approval, Viltepso was approved under FDA’s Fast Track and Priority Review programs. It also carries Orphan Drug and Rare Pediatric Disease Designations. For full prescribing information, look here.
Enspryng Approved to Treat Neuromyelitis Optica Spectrum Disorder
Genentech’s Enspryng™ (satralizumab-mwge) injection was approved by the FDA on Aug. 14, 2020. It is indicated for treating adults who have neuromyelitis optica spectrum disorder (NMOSD) that tests positive for anti-aquaporin-4 (AQP4) antibodies. Symptoms of NMOSD tend to fluctuate, with relapses following periods of relative stability. Enspryng blocks interleukin-6 (IL-6) to decrease the inflammation associated with NMOSD. Unlike other NMOSD treatments, which are administered by IV infusions, Enspryng is given subcutaneously (SC) – meaning that patients and their caregivers can give the injections at home. The recommended dose is one 120mg dose followed by two more that are two weeks apart. Then, injections switch to once every four weeks. Genentech plans a launch within two weeks. After the first year of treatment, which requires two extra doses, annual treatment is expected to cost approximately $190,000. Approved under the FDA’s Breakthrough Therapy designation, Enspryng also has Orphan Drug status for treating NMOSD. Complete prescribing information is here.
Approval of Gene Therapy for Hemophilia A Delayed
On Aug. 18, 2020, BioMarin Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its application for approval of valoctocogene roxaparvovec for the treatment of adults with severe hemophilia A. Valoctocogene roxaparvovec, which has a proposed brand name of Roctavian, is a gene therapy that is administered as a one-time IV infusion. The FDA is requesting two years of data from BioMarin’s ongoing Phase III study to determine if the gene therapy maintains its efficacy in reducing the annualized bleeding rate in treated individuals. FDA indicated that currently-available data do not sufficiently demonstrate durability of effect. BioMarin expects final data from the Phase III trial to be available in November 2021. Approval of valoctocogene roxaparvovec likely will be delayed until 2022. Several other gene therapies in the pipeline for hemophilia. Two new gene therapies may be approved in 2021 for hemophilia B and as many as four gene therapies for hemophilia A may be approved in 2022. FDA possibly will require longer-term data for other hemophilia gene therapies in the pipeline, potentially delaying approval of these agents beyond 2021 and 2022.
New Indication for Xeomin
On August 18, 2020, the FDA approved a new indication for Merz Pharmaceuticals’ Xeomin® (incobotulinumtoxinA) for treating pediatric patients aged two years and older with upper limb spasticity, excluding spasticity caused by cerebral palsy. Upper limb spasticity (inflexibility, spasms or stiffness in the muscles) affects the muscles in the arms, shoulders and neck. Upper limb spasticity is fairly common for children who have had head injuries, spinal cord injuries or strokes. Approval was based on studies that showed Xeomin was effective at improving twelve upper limb muscles, which include clenched fist, flexed wrist, flexed elbow, pronated (twisted) forearm and thumb-in-palm patterns. Treatment should not occur more often than once every 12 weeks. However, dosage and the number of injection sites should be tailored to each individual. The typical dosage for upper limb spasticity will consist of one to two intramuscular (IM) injection sites per muscle ranging from 10 Units to 100 Units. Within the trial, patients were treated safely with up to 400 Units per visit. Xeomin, an acetylcholine release inhibitor and neuromuscular blocking agent, is already approved to treat adults with upper limb spasticity among several other conditions. All botulinum toxin products, including Xeomin, carry a boxed warning that they may migrate away from the areas where they are injected and possibly may cause widespread side effects that rarely may include serious breathing or swallowing problems. Migration and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects. Xeomin’s complete prescribing information is here.
Generic Tecfidera Launched
On Aug. 19, 2020, Mylan announced the launch of its AB-rated generic to Biogen’s Tecfidera® (dimethyl fumarate), an orally administered therapy for treating adults who have relapsing forms of multiple sclerosis (MS). Its recommended maintenance dose is 240mg twice daily. Mylan’s generics are available as 120mg and 240mg capsules, similar to the commercially-available strengths of Tecfidera. This generic launch is considered “at risk” because patent litigation between Biogen and Mylan is ongoing. Pricing is not yet available. The FDA has yet to approve generics from any other generic manufacturer. These generics could be delayed by ongoing litigation, or bound by terms within patent settlement agreements. Additional patent rulings are expected later this year. Biogen’s Vumerity® (diroximel fumarate), a follow-on to the company’s Tecfidera, was approved in October 2019 for treating relapsing forms of MS. Bafiertam™ (monomethyl fumarate), from Banner Life Sciences, is another competitor to Tecfidera. After receiving approval in April of this year, the company is planning a commercial launch in September. According to IQVIA, U.S. sales for Tecfidera were approximately $3.8 billion for the 12 months ending June 30, 2020.
Recordati was given FDA approval on Aug 19, 2020, for Cystadrops® (cysteamine ophthalmic solution) 0.37%. A thickened formulation of cysteamine for use in the eyes, it treats cysteine deposits in the corneas of patients who have cystinosis, an inherited metabolic lysosomal storage disorder that affects an estimated 600 U.S. patients. Cystinosis makes crystals of the protein cystine accumulate in body cells, eventually causing kidney failure, muscle wasting and damage to other organs. If untreated, cystinosis usually is fatal before the age of 10 years. Most patients experience eye pain and sensitivity to light; some lose vision, completely. However, after 90 days, the density of corneal cysteine deposits decreased by up to 40% for patients using Cystadrops in clinical trials and the improvement persisted over the five-year long study. It will be dispensed in boxes containing one 5mL bottle of solution and a separate dropper that is attached after the bottle is opened. Unopened bottles should be kept in the refrigerator, but bottles should be left out at room temperature up to 77⁰ after the dropper is attached. Patients should use one drop in each eye four times a day while awake. Those who wear contact lenses should remove them for dosing and wait for at least 15 minutes before reinserting them. The only other cysteamine eye drop presently FDA approved in the U. S. is Cystaran® (cysteamine ophthalmic solution – Lediant Biosciences) 0.44%, which must be used once every hour while the patient is awake. Here is prescribing information for Cystadrops.
Kesimpta Approved for Relapsing Multiple Sclerosis
Kesimpta® (ofatumumab – Novartis) was approved by the FDA on Aug. 20, 2020. An anti-CD20 monoclonal antibody, Kesimpta is indicated to treat adults who have relapsing forms of multiple sclerosis (RMS). Kesimpta reduces the numbers of B cells – mostly in lymph nodes – by attaching to specific parts of CD20 proteins on B cells. It will be dispensed in single-dose prefilled syringes and pen devices containing 20mg of Kesimpta for SC injection. Patients can self-administer Kesimpta; however, the first injection should be performed under the guidance of a healthcare professional. A second and third dose follow the initial injection at one-week intervals, and then treatment switches to once per month. Launch is planned for early in September. Estimated wholesale acquisition (WAC) cost per dose is roughly $6,900. With the brand name Arzerra®, an IV formulation of ofatumumab was approved by the FDA in 2009 to treat chronic lymphocytic leukemia (CLL). Given at much higher doses than Kesimpta, Arzerra has boxed warnings that it may cause a rare, severe side effect and that it may worsen or rekindle hepatitis hep B. No boxed warnings are associated with Kesimpta, although its labeling cautions patients that it may increase the risk of infections and that it may damage developing babies if used during pregnancy. Complete prescribing information may be found here.
Darzalex and Kyprolis Approved for Combination Treatment of Multiple Myeloma
Janssen was granted expanded FDA approval for its CD38-directed antibody, Darzalex® (daratumumab) to treat multiple myeloma on August 20, 2020. Darzalex now is indicated for use in combination with Kyprolis® (carfilzomib – Amgen) and dexamethasone for the treatment of adult patients who have relapsed/refractory multiple myeloma and who have received one to three previous lines of therapy. Approval was based partially on results from the Phase III CANDOR study that showed Darzalex in combination with Kyprolis and dexamethasone reduced the risk of disease progression or death by 37% compared to treatment with just Kyprolis and dexamethasone. After induction dosing, Darzalex is administered as a 16mg/kg IV infusion once every four weeks. Kyprolis is administered as an IV infusion at a dose of 70mg/m2 once weekly or 56mg/m2 twice weekly. Darzalex and Kyprolis have several previous indications for treating patients with relapsed or refractory multiple myeloma. Updated prescribing information for Darzalex can be found here and for Kyprolis here.
Winlevi, New Acne Treatment Approved
Winlevi® (clascoterone cream 1%) was approved by the FDA on Aug. 26, 2020. Its indication is to treat acne for patients who are at least 12 years old. The first androgen receptor blocker to be approved for use on the skin surface, it works differently than other currently available topical acne treatments. By interfering with androgen in the skin’s sebaceous glands and hair follicles, Winlevi is thought to lessen sebum release and lower inflammation. It will be marketed in 60gm tubes with directions to apply a thin layer of approximately one gram of cream to affected areas twice a day, avoiding the eyes, mouth and mucous membranes. It may be used in combination with other acne products, such as antibiotics and retinoids. The manufacturer, Cassiopea, expects to launch Winlevi in the early part of 2021 at a price to be determined in the fourth quarter of 2020. For its full prescribing information, look here.
MedWatch Update: Invokana/Invokamet/Invokamet XR
The FDA has removed one boxed warning from the labels of Janssen’s Invokana® (canagliflozin), Invokamet®(canagliflozin/metformin) and Invokamet® XR (canagliflozin/metformin extended-release) tablets. All three drugs are used along with diet and exercise to treat type 2 diabetes. They also are indicated to decrease the risk of cardiovascular (CV) events for patients who have diabetes and CV disease and to lower the risk of end-stage renal (kidney) disease (ESRD) for some patients who have diabetes and diabetic nephropathy. Based on new information from clinical trials, the FDA has determined that taking the drugs is not associated as strongly as first believed with an increase in amputations. Although patients, caretakers and prescribers are reminded to follow guidelines for good foot care among patients who have diabetes, the boxed warning is no longer needed. Because metformin can cause lactic acidosis (a potentially dangerous build-up of lactic acid in the blood), Invokamet and Invokamet XR will continue to carry a boxed warning for that possible side effect. More information about the change is here.
Recall: Bayshore Metformin Extended Release
On Aug. 20, 2020, Bayshore Pharmaceuticals recalled metformin extended-release tablets, 500mg and 750mg due to the FDA’s finding that some tablets had unacceptable levels of the probable carcinogen, N-nitrosodimethylamine (NDMA). Extended-release metforminis a common initial treatment choice for patients who have type 2 diabetes. No immediate-release metformin is being recalled; and not all the extended-release forms are affected. The Bayshore notice is here. For the FDA’s general information pages, look here and here.
Recall: RLC Labs’ Thyroids
RLC Labs recalled all of its levothyroxine/liothyronine products – Nature-Throid, Westhroid and WP Thyroid on Aug. 25, 2020. They are used to replace low or missing natural thyroid due to deficiencies, radiation or surgery. Samples of the drugs were found to contain less than 90% of active ingredients, which is below the FDA’s minimum standard. Although lower than expected doses are not especially dangerous to patients, they could lead to under treatment and unnecessary dose changes. Here is additional information.
Sogroya Receives FDA Approval
A new human growth hormone product, Novo Nordisk’s Sogroya® (somapacitan-beco) injection 10 mg/ 1.5 mL, was approved by the FDA on Aug. 28, 2020. It is indicated for use by adults who have growth hormone deficiencies (GHD). Although GHD most often is associated with the lack of normal growth in children, approximately 6,000 American adults are diagnosed as having it each year. Up to about 20% are continuations of childhood deficiencies, with the majority of cases resulting from damage to the pituitary gland from accidents, radiation, surgery or tumors. For adults, GHD symptoms are general lack of energy, muscle weakness and weight gain– particularly in the abdomen. Anxiety and depression levels also may be elevated. To treat adults who have GHD, Sogroya will be injected SC once each week through a single-dose, prefilled syringe. The initial dose of 1.5mg will be increased every two to four weeks until the dose reaches greatest effectiveness or the patient is using a maximum of 8mg/week. The several other human growth hormone products that are available in the U.S. for adult use must be injected on a daily basis. Plans for the cost and launch for Sogroya still are in development. Its prescribing information is here.