Posts in category: Uncategorized

Chiesi Global Rare Diseases, (a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group, Chiesi Group), has announced that the FDA has approved Lamzede (velmanase alfa-tycv) the first and only enzyme replacement therapy for the treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients.

AM is an ultra-rare, progressive lysosomal storage disorder caused by deficiency in the enzyme αmannosidase, and Lamzede is indicated for the treatment of both adult and pediatric patients.

The prevalence of AM is approximately one in every 500,000 to one in every 1,000,000 babies born worldwide. AM results in the body’s cells being unable to properly break down certain groups of complex sugars. The buildup of sugars can affect many of the body’s organs and systems. Effects of the disease vary significantly from person to person and progress over time.

The most common adverse reactions (incidence >20%) are hypersensitivity reactions including
anaphylaxis, nasopharyngitis, pyrexia, headache, and arthralgia.

Lamzede may cause embryo-fetal harm when administered to a pregnant female. A negative pregnancy status must be verified in females of reproductive potential prior to initiating the medication. Patient should be advised to use effective contraception during treatment and for 14 days after the last dose of Lamzede.

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IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.

This recall does not apply to TIROSINT® (levothyroxine sodium) capsules.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent TIROSINT®-SOL, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may
include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. Over or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism.

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Shop Me Ca of Herndon, VA is recalling its 10-gram tubes of “Diep Bao Cream” because they have the potential to be contaminated with lead. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems.

Diep Bao Cream was sold nationwide through Shop Me Ca’s Facebook page and a Vietnamese Moms’ Facebook groups: Hội Mẹ Việt Nuôi con Tại Mỹ, Mẹ Việt Tại Mỹ, Chuyên Đồ Bầu và Chăm Sóc Sau Sinh, and Nguyễn Ngọc. These Facebook groups are not associated with Shop Me Ca.

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy

Smiths Medical is recalling certain CADD Administration Sets and Medication Cassette Reservoirs, used with the CADD ambulatory infusion system, for two issues: a risk of tubing occlusion and a risk of false “No Disposable Attached (NDA)” alarms. Either of these issues can cause delay of therapy, interruption 12 Drug News – Volume 10, Issue 2
of therapy, or under-delivery of medication, which all have the potential to cause serious patient harm or death.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.

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Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible
contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended
Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GESCRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection. Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC – by phone: 1-518-738-7602 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm
EST; or DELSAM Pharma LLC by phone: 1-866-826-1309 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare
provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA0178

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FDA Approves Trodelvy (sacituzumab govitecan-hziy)for patients with
specific metastatic hormone recepter breast cancers having received
endocrine-based therapy and at least two additional therapies.

The Food and Drug Administration has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Trodelvy (sacituzumab govitecan-hziy) is a targeted-chemotherapy drug used to treat certain types of breast and urothelial cancers (a type of bladder cancer). Trodelvy is an antibody-drug conjugate containing an antibody called sacituzumab linked to govitecan (SN-38), a chemotherapy drug.

Sacituzumab targets and attaches to a protein called Trop-2, which is overexpressed on the surface of certain cancer cells. The antibody-drug conjugate is then internalized into the cancer cell where the linker between the antibody and drug is broken by a process called hydrolysis, releasing the chemotherapeutic govitecan into the cancer cells.

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FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic
Kidney Disease for Adults on Dialysis

The U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Other FDA-approved treatments for this condition are injected into the blood or under the skin. The FDA granted the approval to GlaxoSmithKline LLC.

Jesduvroq is not approved for patients with anemia due to chronic kidney disease who are not on dialysis because its safety has not been established in that population.

The most common side effects of Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.

Patients should not use Jesduvroq if they also take certain drugs that cause increased levels of Jesduvroq or if they have uncontrolled high blood pressure.

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The Menarini Group, a leading Italian pharmaceutical and diagnostics company, has announced that the U.S. Food and Drug Administration (FDA) has approved Orserdu for the
treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is approved under the FDA’s Priority Review and Fast Track designation.

• ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.
• ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have
  been difficult to treat.
• Orserdu is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need.

Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York will commercialize Orserdu in the U.S.

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Jaypirca (pirtobrutinib) approved for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

Loxo@Lilly, the oncology unit of Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Jaypirca, a highly selective kinase inhibitor, utilizes a novel binding mechanism and is the first and only FDA approved non-covalent (reversible) BTK inhibitor. It was approved under the FDA’s Accelerated
Approval pathway based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial. Continued approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.

Jaypirca is expected to be available in the United States in the coming weeks.

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Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration has approved zanubrutinib (Brukinsa), manufactured by the biotechnology company BeiGene, which is a next-generation BTK inhibitor, for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA reported that the most common adverse reactions seen with zanubrutinib were a decrease in neutrophil count, upper respiratory tract infection, decrease in platelet count, hemorrhage, and musculoskeletal pain.

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