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fda-approved1

Several New Cancer Fighting Drugs Approved by the FDA

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According to Merriam-Webster, the definition of cure is:
1a: to restore to health, soundness, or normality; 1b: to bring about recovery from; 2a: to deal with in a way that eliminates or rectifies.

Though researchers have not found the ‘cure’ for cancer, they are finding ways to treat all types of cancers in hopes of providing relief and hopefully remission to those who are facing treatments for this disease. The following are the newest drugs that have been approved by the FDA in recent months to treat various cancer types in hopes of providing relief or remission.

Copiktra (duvelisib) by Verastem was approved in September for the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma or follicular lymphoma.

Copiktra is specifically indicated for the treatment of adults with 1) relapsed or refractory chronic lymphocytic leukemia, 2) small lymphocytic lymphoma after at least two prior therapies and 3) relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

Copiktra is supplied as a capsule for oral administration. The recommended dose is  25 mg administered as oral capsules twice daily (BID) with or without food in 28 day cycle. The capsules should be swallowed whole and not opened, broken, or chewed.

Side effects may include diarrhea or colitis, neutropenia (abnormally low count of a type of white blood cell), rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, anemia.

Daurismo (glasdegib) by Pfizer was approved in November for the treatment of newly-diagnosed acute myeloid leukemia in adults 75 years of age or older.

Daurismo is specifically indicated for use in combination with low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

Daurismo is supplied as a tablet for oral administration. The recommended dose of is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response.

Daurismo can be taken with or without food and should be administered about the same time each day. Do not split or crush tablets. If a dose of Daurismo is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of Daurismo is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer two doses of Daurismo within 12 hours.

Daurismo does include a Black Box warning and symptoms may include anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, and decreased appetite to name a few.

Libtayo (cemiplimab-rwlc) from  Regeneron Pharmaceuticals was approved in September for the treatment of cutaneous squamous cell carcinoma.

Libtayo is specifically indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Libtayo is supplied as an intravenous solution with a recommended dosage of 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Side effects of Libtayo may include fatigue, rash, and diarrhea.

Lorbrena (lorlatinib) from Pfizer was approved in November for the treatment of ALK-positive metastatic non-small cell lung cancer.

Lorbrena is specifically indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer whose disease has progressed on 1) crizotinib and at least one other ALK inhibitor for metastatic disease; or 2) alectinib as the first ALK inhibitor therapy for metastatic disease; or 3) ceritinib as the first ALK inhibitor therapy for metastatic disease.

Lorbrena is supplied as a tablet for oral administration. The recommended dosage is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Tablets should be swallowed whole and should not be chewed, crushed or split out. Tablets should not be ingested if they are broken, cracked, or otherwise not intact. Lorbrena should be administered at the same time each day. Do not take two doses at the same time to make up for a missed dose. Do not take an additional dose if vomiting occurs after Lorbrena but continue with the next scheduled dose.

Adverse effects associated of Lorbrena may include edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea.

Lumoxiti (moxetumomab pasudotox-tdf) from AstraZeneca was approved in September for the treatment of relapsed or refractory hairy cell leukemia.

Lumoxti is specifically indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Lumoxiti is supplied as a solution for intravenous injection. The recommended dose of Lumoxiti is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity.

Adverse effects associated with the use of Lumoxiti may include infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, diarrhea.

Poteligeo (mogamulizumab-kpkc) from Kyowa Kirin was approved in August for the treatment of mycosis fungoides or Sézary syndrome. Poteligeo is specifically indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Poteligeo is supplied as a solution for intravenous administration. The recommended dose is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer Poteligeo within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer Poteligeo subcutaneously or by rapid intravenous administration.

Side effects associated with the use of Poteligeo may include rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, upper respiratory tract infection.

Talzenna (talazoparib) from; Pfizer was approved in October for the treatment of deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer,

Talzenna is specifically indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

Talzenna is supplied as a capsule for oral administration. The recommended dose of Talzenna is 1 mg taken orally once daily, with or without food. A 0.25 mg capsule is available for dose reduction. Patients should be treated until disease progression or unacceptable toxicity occurs. The capsule should be swallowed whole and must not be opened or dissolved. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.

Side effects associated with the use of Talzenna fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite.

Vitrakvi (larotrectinib) from Loxo Oncology was approved in November for the treatment of solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Vitrakvi is specifically indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity, and; have no satisfactory alternative treatments or that have progressed following treatment.

Vitrakvi is supplied as both a capsule and an oral solution. The recommended dose regimen is dependent on the size of the patient and is provided orally twice daily, with or without food, until disease progression or until unacceptable toxicity.

Side effects associated with the use of Vitrakvi may include , fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation diarrhea.

Vizimpro (dacomitinib) from Pfizer was approved in September 2018 for the treatment of metastatic non-small cell lung cancer.

Vizimpro is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Vizimpro is supplied as a tablet for oral administration. The recommended dose is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Vizimpro can be taken with or without food and should be administered at the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose.

Side effects may include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, pruritus.

Xospata (gilteritinib) from Astellas was approved in November for the treatment of acute myeloid leukemia with a FLT3 mutation.

Xospata is specifically indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

Xospata is supplied as a tablet for oral administration. The recommended starting dose is 120 mg orally once daily with or without food. Response may be delayed. In the absence of disease progression or unacceptable toxicity, treatment for a minimum of 6 months is recommended to allow time for a clinical response. Do not break or crush Xospata tablets. Administer tablets orally about the same time each day. If a dose of Xospata is missed or not taken at the usual time, administer the dose as soon as possible on the same day, and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours.

Side effects associated with the use of Xospata may include myalgia/arthralgia, transaminase, increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness, and vomiting.

fda-approved1

New FDA Approvals

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Several new drugs have been approved since April of this year including treatments for migraine, liver disease, kidney disease, and those facing opioid withdrawal symptoms.

Aimovig (erenumab-aooe) from Amgen has been approved for the preventive treatment of episodic or chronic migraine in adults. Aimovig is supplied as an injection with a recommended dosage of 70 mg once per month. Some patients may benefit from two injections of 70 mg once per month. If a dose of Aimovig is missed, another dose should be administered as soon as possible.

Adverse reactions associated with the use of Aimovig may include, but are not limited to, the following:

  • injection site reactions
  • constipation

For those with a rare, inherited, disorder known as X-linked hypophosphatemia (XLH) Crysvita (burosumab-twza) from Ultragenyx has recently been approved.

XLH is characterized by low levels of phosphate in the blood. Phosphate levels are low because phosphate is abnormally processed in the kidneys, which causes a loss of phosphate in the urine and leads to soft, weak bones (rickets).This genetic disorder affects about one in 20,000 people and is typically, it is passed from one generation to the next, but sometimes appears in an individual with no family history of XLH.

Crysvita is specifically indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older and is supplied as an injection every two to four weeks depending on the age of the patient and the length of treatment.

Side effect may include, but are not limited to:

Pediatrics:

  • headache
  • injection site reaction
  • vomiting
  • pyrexia
  • pain in extremity
  • vitamin D decreased

Adults:

  • back pain
  • headache
  • tooth infection
  • restless leg syndrome
  • vitamin D decreased
  • dizziness
  • constipation
  • blood phosphorus increased

AndexXa (coagulation factor Xa (recombinant), inactivated-zhzo) by Portola Pharmaceuticals has recently been approved for the reversal of factor Xa inhibitors. AndexXa is administered via intravenous injection.

This is the first and only antidote indicated for patients treated with drugs such as rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Factor Xa inhibitors are anticoagulants used to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Side effects include:

  • urinary tract infections
  • pneumonia

Two new drugs have been approved for the treatment of thrombocytopenia (low blood platelet count).

Doptelet (avatrombopag) from AkaRx has been approved for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure that would typically require platelet transfusion. Doptelet is supplied as a tablet for oral administration with dosing beginning 10-13 days prior to the scheduled procedure.

Side effects may include, but are not limited to:

  • pyrexia
  • abdominal pain
  • nausea
  • headache
  • fatigue
  • edema peripheral

Tavalisse (fostamatinib disodium hexahydrate) from Rigel Pharmaceuticals has been approved for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.

Tavalisse (fostamatinib disodium hexahydrate) is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK).

Tavalisse is supplied as a tablet for oral administration with an initial dose of 100 mg taken orally twice daily for a month. Depending on platelet county, dosage may be increased. Tavalise may be taken with or without food.

Side effects may include:

  • diarrhea
  • hypertension
  • nausea
  • respiratory infection
  • dizziness
  • ALT/AST increased, rash
  • abdominal pain
  • fatigue
  • chest pain
  • neutropenia

For those with higher than normal potassium levels—known as hyperkalemia—Lokelma (sodium zirconium cyclosilicate) from AstraZeneca has been approved. Lokelma is a highly-selective, oral potassium-removing agent.

Lokelma is administered orally as a suspension in water for oral administration. The recommended dose is 10 g administered three times a day for up to 48 hours. For continued treatment, the recommended dose is 10 g once daily. The most common adverse reaction associated with the use of Lokelma is mild to moderate edema.

Palynziq (pegvaliase-pqpz) from BioMarin has been approved for the treatment of phenylketonuria. Phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. Phenylalanine is a building block of proteins (an amino acid) that is obtained through the diet. It is found in all proteins and in some artificial sweeteners.Without treatment, phenylalanine builds up in the blood and causes health problems.

Playnziq is specifically indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Side effects of Palynziq may include:

  • injection site reactions
  • arthralgia
  • hypersensitivity reactions
  • headache
  • generalized skin reactions lasting at least 14 days
  • pruritus
  • nausea
  • abdominal pain
  • oropharyngeal pain
  • vomiting
  • cough
  • diarrhea
  • fatigue

Jynarque (tolvaptan) by Otsuka America has been approved for the treatment of autosomal dominant polycystic kidney disease (PKD). PKD is a genetic disorder characterized by the growth of numerous cysts filled with fluid in both kidneys. The progressive expansion of PKD cysts slowly replaces much of the normal mass of the kidneys, and can reduce kidney function and lead to kidney failure.

Jynarque is a selective vasopressin V2-receptor antagonist that is specifically indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.

Jynarque is supplied as a tablet for oral administration. The recommended initial dose is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later. Titrate to 60 mg plus 30 mg then to 90 mg plus 30 mg per day if tolerated with at least weekly intervals between titrations. Patients may down-titrate based on tolerability.

Adverse effects associated with the use of Jynarque may include, but are not limited to:

  • thirst
  • polyuria
  • nocturia
  • pollakiuria
  • polydipsia

Jynarque (tolvaptan) is not without risk and can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported.

Lucemyra (lofexidine) by US Worldmeds has been approved for the mitigation of opioid symptoms to facilitate abrupt opioid discontinuation in adults.

Lucemyra is supplied as a tablet for oral administration. The usual starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of Lucemyra should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets).

Lucemyra treatment may be continued for up to 14 days with dosing guided by symptoms.  Discontinue Lucemyra with a gradual dose reduction over a 2- to 4-day period to mitigate Lucemyra withdrawal symptoms.

Adverse effects associated with the use of Lucemyra may include, but are not limited to:

  • orthostatic hypotension
  • bradycardia
  • hypotension
  • dizziness
  • somnolence
  • sedation
  • dry mouth

Lucemyra may cause low blood pressure or slower heart rate and should be used with caution in patients diagnosed with low blood pressure, slow heart rate, any other cardiac abnormality (including prior diagnosis or family history of long QT syndrome), or prior heart attack.

 

FDA Approvals for 4th Quarter of 2015

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Recently, the following drugs have received approved by the FDA:
Gilead Sciences received approval in November for Genvoya in the treatment of HIV-1 infection.
Those needing management of osteoarthritis pain now have another option in Vivlodex from Iroko Pharmaceuticals.
Aristada from Alkermes received approval for the treatment of schizophrenia.
Those suffering from severe pain may find relief in Belbuca from Endo Pharmaceuticals.
Several new cancer treatments are now available:
Alecensa from Roche has been approved for the treatment of ALK-positive, metastatic non-small cell lung cancer.
Cotellic from Genentech was approved in November for the treatment of BRAF V600E or V600K melanoma.
Janssen Biotech has received approval for Darzalex for the treatment of multiple myeloma.
For the treatment of patients with multiple myeloma who have received prior therapies, Empliciti from Bristol-Myers Squibb has been approved.
Imlygic from Amgen has been approved for the treatment of unresectable recurrent melanoma.
Millennium Pharmaceuticals has been approved for Ninlaro for the treatment of multiple myeloma.
Onivyde from Merrimack has been approved for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
A new treatment for metastatic squamous non-small cell lung cancer has been approved: Portrazza from Eli Lilly.
AstraZeneca has been approved for Tagrisso for the treatment of EGFR T790M mutation positive non-small cell lung cancer.
Those suffering from liposarcoma or leiomyosarcoma be find relief in Yondelis by Janssen which as approved in October.
Two new treatments for those with lung disease are now available:
Nucala from GlaxoSmithKline has been approved for the treatment of severe asthma with an eosinophilic phenotype.
For the long-term maintenance treatment of airflow obstruction in patients with COPD, Utibron Neohaler from Novartis has been approved.
 
For more information about these new medications, talk to your doctor for pharmacist to find out more.

2015 In Review

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Looking back at 2015, we have covered many topics that, hopefully, have been of interest and help to you. If, by chance, you’ve missed any of them, the full list of articles along with their links are listed below.
We are thankful to all of our customers more than you’ll ever know and look forward to serving you in 2016.
Elderly Care
Caregiver Tips
Be Informed about Medications
Be a Good Neighbor

Heart Care
Heart Awareness Month
Keeping Your Heart in Shape (Part One)
Keeping Your Heart in Shape (Part Two)
Diabetic Care
Foot Care
Eating Well
Diabetic Risk Test
Health Tips and News
Healthy Summers
Benefits of Drinking Water
Blood Donations
Handling Stress
Getting a Good Night Sleep
When to Take Antibiotics
Vitamin Tips
Women’s Health Tips
Travel Tips
Joint Pain Prevention
Kids Health
Juvenile Arthritis
Are your Teenagers Getting Enough Sleep?
Summer Camp
Back to School
Disease Awareness
Colorectal Cancer Awareness
Measles Facts
Is it Acid Reflux or Heartburn?
Alzheimers Disease
Skin Care
How to Treat Acne
Damaging Effects of the Sun
Weight Management
Eating Less over the Holidays
Underlying Causes of Weight Gain
Colds and Flu
Time for Your Flu Shot
Winning the Sore Throat Battle
Treating a Sore Throat
Pharmacy News
American Pharmacist Month
Pharmacists are a Trusted Resource
Clinical Trial Participation
Great American Smokeout
FDA Approvals
End of 2014 Drug Approvals
First Quarter Drug Approvals
Second Quarter Drug Approvals
Two New Drugs Approved
Drug Abuse Issues
Drug Take-Back Day
Project Lazarus
Poison Prevention
 HIV Outbreak
 Be Street Smart
 
 

When should you take antibiotics?

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So you’re not feeling well. Maybe you have a sore throat or your sinuses are wreaking havoc in your head? How do you know if you need an antibiotic or if an antihistamine or analgesic is enough?
If you are suffering from the common cold or the flu, an antibiotic will not help you. Antibiotics only work on illnesses caused by bacteria and they are not effective against viruses.
You should consult your doctor if you think you have a bacterial infection. If a physical exam is not enough to determine the cause of your illness, then he or she may also order a blood or urine test to confirm a diagnosis. Once the doctor determines whether an infection, or a simple virus, he or she may prescribe you with an antibiotic.
Be sure to follow the exact instructions for taking the medication. Prescriptions are written to cover the time needed to help your body fight all the harmful bacteria. If you stop your antibiotic early, the bacteria that have not yet been killed can restart an infection.
Don’t think that you can save your medication for one infection and use it for another infection later on. Leftover antibiotics are not a complete dose, and they will not work to kill all your disease causing bacteria. Always talk to your doctor because your symptoms may not be caused by bacteria. If you do have another bacterial infection, a complete dose of the appropriate antibiotic is needed to kill all the harmful bacteria. And the medication prescribed for an earlier infection may not work on a later infection — especially if you only have a partial dose.
How safe are antibiotics?
Antibiotics are generally safe and should always be taken as prescribed by your doctor. However, they may alter the effectiveness of other medications and cause side effects or allergic reactions. If you are experiencing any adverse effect of your medicine, consult your doctor right away.
Antibiotics can kill most of the bacteria in your body that are sensitive to them and that includes good bacteria. By destroying the bacterial balance, it may cause upset stomach, diarrhea, vaginal infections, or other problems.
If you take antibiotics unnecessarily you may contribute to the development of antibiotic resistance. If you become sick and your bacteria are resistant to your prescribed antibiotic, your illness lasts longer and you may have to make return office and pharmacy visits to find the right drug to kill the germ. For more serious infections it is possible that you would need to be hospitalized or could even die if the infection could not be stopped. Also, while the resistant bacteria are still alive, you act as a carrier of these germs, and you could pass them to friends or family members.
How does a doctor decide which antibiotic to prescribe?
Your doctor will examine you and consider all of your symptoms in order to tell if they should prescribe an antibiotic and, if so, which one. Physicians can also take a culture to see if bacteria are causing a particular illness, such as a throat culture to determine if you have strep throat. If the cause of the infection is unclear, but suspected to be due to bacteria, the doctor may prescribe a broad-spectrum antibiotic that is useful for controlling a wide variety of bacterial types. The physician may choose either a generic or name-brand antibiotic depending on your circumstances.
What should women know before taking antibiotics?
Antibiotics often lead to a vaginal yeast infection. Because antibiotics kill the normal bacteria in the vagina, yeast no longer have competition for food and grow rapidly. Yeast cells begin attacking tissues in the vagina, usually causing one or all of the following symptoms: itching, burning, pain during sex and vaginal discharge. If you think you have a yeast infection, consult a physician.
Antibiotics may also reduce the effectiveness of birth control pills.
As with other medications, some antibiotics may be transmitted to a fetus, and some may cause harm. Therefore, you should never take antibiotics without your doctor’s knowledge if you are pregnant or nursing.

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