Medical uses of Melphalan Injection

Melphalan belongs to a group of drugs called cytotoxics (also called chemotherapy). It is approved in order to be used for the treatment of cancer. It works in order to reduce the number of abnormal cells formed in the body. 

The melphalan 50 mg injection is specifically used for:

• Multiple myeloma: a type of cancer that forms from cells in the bone marrow called plasma cells. Plasma cells help in order to fight infection and disease by producing antibodies. 
• Advanced cancer of the ovaries
• Childhood neuroblastoma: cancer of the nervous system. 
• Malignant melanoma: skin cancer. 
• Soft tissue sarcoma: cancer of the muscle, fat, blood vessels, fibrous tissue, or other supporting tissue of the body.

Approval: In the year of 1964, Melphalan was approved for medical use in the United States.

Melphalan specifically belongs to the class of nitrogen mustard alkylating agents. It acts in order to interfere with the formation of DNA and RNA. 

Dosage Form: Melphalan comes in the form of injection generically and under the brand name Alkeran. Melphalan should only be prescribed for you by a specialist healthcare professional, experienced in order to treat blood problems or cancer. 

The recommended dose of melphalan injection can be administered as an infusion into your vein or as a perfusion to a particular part of the body through an artery.

Your healthcare provider will determine how much melphalan you will have. The amount of this medication depends on:

• your body weight or body surface area (a specific measurement taking into account your weight and your size). 
• other medicines you are having
• your disease
• your age
• whether or not you have kidney problems.

When you're administered melphalan, your healthcare team will take regular blood tests. This is in order to check the number of cells in the blood. Your healthcare professional may sometimes change your melphalan dose as a result of these tests.

Side Effects: Side effects of melphalan are usually mild and not life threatening. The commonly reported side effects may include fatigue, decreased WBC count, decreased lymphocyte count, decreased platelet count, diarrhea, nausea, hypokalemia, anemia, and vomiting.

Cost: The melphalan price in India may vary depending on the wholesaler/pharmacy and of course the brand you choose. The cost of melphalan ranges from around 2,199 INR to 2,500 INR for a supply of vial of 1 injection. 

Polykris (Polymyxin-B): All you need to know about

Introduction: Polymyxin-B is an antibiotic drug, comes under the branded generic name Polykris. Polykris is marketed by Ikris Pharma (Pharmaceutical Wholesaler). Polykris is introduced for the treatment of meningitis, pneumonia, urinary tract infections and sepsis. It is effective for several Gram-negative infections. Although, it is ineffective for Gram-positive infections. Polykris contains a Lyophilized form of polymyxin b sulphate as an active ingredient. 

Indications for Use: Polymyxin-B sulfate is a drug of choice to treat infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa.

This medication may also be used topically and subconjunctivally to treat infections of the eye caused by susceptible strains of Ps. aeruginosa.

The polymyxin b sulphate may be used in serious infections caused by susceptible strains of H. influenzae, specifically in meningeal infections, Escherichia coli, specifically in urinary tract infections, Aerobacter aerogenes, specifically in bacteremia and Klebsiella pneumoniae, specifically in bacteremia, when less potentially toxic medicines are not useful or contraindicated.

Dosage and Administration: Dosage and administration information for polymyxin B USP 500000 IU (Polykris) varies widely depending on the reference used. It should be used as directed by a healthcare professional. 

Intravenous (children, adults):

• 15,000 to 25,000 units/kg/day (normal renal function)
• 15,000 units/kg/day (renal impairment)
• Total daily polymyxin-b dose not to exceed 25,000 units/kg/day

Intravenous (adults):

• 12,500 to 15,000 units per kg (TBW) administered over one hour every 12 hours. 
• No dose adjustments are required in patients with renal impairment. 
• Total daily polymyxin-b dose: 30,000 units/kg/day.

Side Effects: The commonly noted side effects of polymyxin b when used by injection include kidney problems, neurological problems, fever, itchiness, and rash. Injections into muscles may result in significant pain. Other serious side effects of polymyxin may include anaphylaxis, fungal infections, and muscle weakness. It is not clear if the use of this drug during pregnancy is safe for the fetus.

Warnings and Precautions:

• Polymyxin-B injection need to be used where sensitivity suggests more commonly used systemic antibacterial agents may be contraindicated or ineffective due to bacterial resistance.
• Polymyxin Injection, if prescribed for intravenous, intramuscular or intrathecal administration, needs to used only in hospitalized patients under precise monitoring for kidney function as well as neurological signs/symptoms.
• In order to reduce the development of drug-resistant bacteria and maintain the impact of polymyxin-B sulfate and other antibacterial drugs, polymyxin-B should be considered only to treat/prevent infections that are proven or strongly suspected to be caused by the susceptible bacteria.
• Patients who are known to hypersensitive to polymyxins, including polymyxin B sulfate, or to any component of the container should not use this medicine. This injection is contraindicated in patients with myasthenia gravis.
• The concurrent/sequential administration of anaesthetic and other neurotoxic medicines needs to be avoided with Polykris treatment. The neurotoxicity of this drug can result in respiratory paralysis from neuromuscular blockade, mainly when the medicine is given soon after muscle relaxants and/or anaesthesia. In case signs of respiratory paralysis occurs, assist respiration and withdraw the medicine.
• Injection Polymyxin B sulphate is not active and therefore do not use to treat bacterial infections caused by gram-negative bacteria (Proteus spp., Morganella spp., Providencia spp., Serratia marcescens, Neisseria spp., Burkholderia spp.), all gram-positive bacteria and anaerobes.
• The intramuscular, intravenous, or intrathecal administration of Polymyxin injection should be restricted to hospitalized patients so as to provide constant clinical supervision. Do not exceed the maximum dosage 2.5 mg/kg/day or a total of 200 mg/day in patients with normal renal function.

Contraindications: The polymyxin b injection USP is contraindicated in recipients with a prior history of hypersensitivity reactions to it.

Drug Interactions:

Use of neuromuscular blockers (curariform muscle relaxants) and neurotoxic medications (e.g., ether, tubocurarine, succinylcholine, gallamine, decamethonium, sodium citrate) is not recommended. 

Do not use concomitant nephrotoxic drugs when feasible (calcineurin inhibitors, IV contrast, vasopressors, loop diuretics, aminoglycosides, ACEI, NSAID, vancomycin, rifampin). 

How Supplied: Polykris (polymyxin antibiotic) is generally supplied as 500,000 units, powder for injection. 

Storage: Before the reconstitution, store it at controlled room temperature 15° to 30°C (59° to 86°F). Protect from light. Retain in carton until time of use.

Following the reconstitution, polymyxin b sulfate must be stored under refrigeration, between 2° to 8°C (36° to 46°F). And any unused portion is discarded after 72 hours.

Cost: A patient weighing between 70 kg to 100 kg and receiving a dose of 30,000 units/kg/day would use 5-6 vials of polymyxin B sulfate, which would cost reasonably not expensive. To know the polymyxin b injection price (Polykris) for a 500MU vial, please get in touch with Ikris Pharma immediately. Furthermore, One can reach out to us by either calling our Toll-Free Number: 18008891064 or sending a WhatsApp message to +91 8130290915.

Note: The piece of information provided about "Polykris (Polymyxin-B): All you need to know about" in this article is just for informational purposes and is not served as a substitute for the medical treatment, consultation, diagnosis, of a qualified doctor.

Contract Manufacturing In India: Third-Party Manufacture

 According to a late 2016 report by Technavio, the global pharmaceutical contract manufacturing market was valued at 65.10 Billion USD in the year of 2016, and by the year of 2022, the same is estimated to touch 94.38 Billion USD. 

In terms of volume and value, India is the 3'rd and 13'th largest Pharma manufacturer respectively. The country is contributing approximately 10% to global production.

The industry of India Pharma as a whole grew by 18% for the last decade. Clearly, the facts and figures of the industry for the past few years are evidence that India has not only entered the global Pharma map, but is here to stay.

India has a vital role in the production and supply of medicines at international level, as, currently more than 80 percent of the FDA-approved antiretroviral medicines used globally in order to combat AIDS are significantly supplied by the Indian pharmaceutical companies/firms.

What is Contract Manufacturing: Contract manufacturing typically refers to the outsourcing of certain production activities of a pharmaceutical company/firm to 3'rd-party vendors. This could include the outsourcing of the production of parts, components, or the finished product itself. For instance, the pharmaceutical companies/firms share the chemical composition or formula of a medicinal product with pharmaceutical CMO (Contract Manufacturing Organizations) which in turn mass manufacture them at their facilities.

The high degree talent pool and best affordable labour in terms of comparative costs have established India one of the most preferred places for contract manufacturing and firms from Europe and USA and of late from Japan have already started shifting towards India in a significant way mostly through collaborative settings and facility sharing.

Contract manufacturing is progressively recognized as a strategic choice by Pharma players to enlarge their global market footprint for zillions of reasons. The major drivers among others for the growth in Pharma contract manufacturing are:

• Dwindling profit margins in highly competitive global Pharma marketplace;

• Growing demand for generic medicines; patent expiration of significant therapeutic brands;

• Demand for up-to-date processes;

• Requirement for high-quality & D facilities and cost-effective production technologies that meet the global regulatory requirements;

• Initiatives by government in healthcare sector;

• Innovation/advancement in biologics and great potency API; and

• Escalation in the incidence and growth rate of cancer, cardiovascular diseases, diabetes and psychological illnesses.

Role of Ikris Pharma Network (IPN) in Contract Manufacturing: Ikris Pharma Network provides Contract manufacturing services to the pharmaceutical companies / Hospital for manufacturing products under their brand / private label manufacturing. This is as per the regulatory requirements of the specific country. India is a well-known hub of World Pharmaceutical Manufacturing.

There are so many advantages for getting pharmaceutical medicinal products manufactured from India. India is engaged/involved in providing or supplying best quality Generic medicines to the world. There are over 10,500 manufacturing companies, based in India. There are over 600 manufacturing plants in India, approved by USFDA.

If you're looking for Contract Manufacturing/Private Label Manufacturing, then Ikris Pharma Network (IPN) can be your one stop solution. Please get in touch with us either via our TOLL-FREE: 1800-889-1064, Or Call/WhatsApp: +91 8130290915, Or Email: info@ikrispharmanetwork.com. IKRIS'ians are here for you whenever you need us. 

U.S. Government Orders 2.5 Million Doses of Monkeypox Vaccines from Bavarian Nordic

Bavarian Nordic A/S announced that the U.S. BARDA also known as Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, has ordered an additional 2.5M (Million) doses of liquid-frozen JYNNEOS, a non-replicating smallpox vaccine and the only vaccine against monkeypox, which is approved by the FDA. 

So far, approximately 1,470 cases of monkeypox, which can cause skin lesions and flu-like symptoms, have been reported in the country, mostly among men who have sex with men. 

Health officials forecast an increase in cases in the coming days due in part to increased reporting of the disease and more testing, US CDC Director Rochelle Walensky uttered in a press briefing.

No cases of monkeypox have been identified among adolescents in the country since testing was expanded to commercial labs last week, she said.

The new order follows a couple of previous orders from the Biomedical Advanced Research and Development Authority in June and July 2022 for 500,000 and 2.5 Million doses respectively, together with an order from the Biomedical Advanced Research and Development Authority in 2020 for 1.4 million doses, will bring the total deliveries in 2022 and 2023 to around 7 million doses.

This extra order will be filled at the US-based contract manufacturer using bulk vaccines already manufactured and invoiced under previous contracts with Biomedical Advanced Research and Development Authority and currently stored at Bavarian Nordic. A tech transfer of the process to the contract manufacturer will begin promptly, with the aim to manufacture all doses under this contract in 2022.

According to Paul Chaplin, President, and CEO of Bavarian Nordic, “Enhancing our manufacturing potential into the US enables the company to deliver more vaccines of Monkeypox in order to match the immediate worldwide requirement for JYNNEOS. This immediate response to a serious health crisis is only possible because the Government of the US is diligent in long-term planning for their national preparedness.”

About Bavarian Nordic:

Bavarian Nordic, is a fully integrated vaccine firm that is focused on the manufacturing, development, and commercialization of life-saving vaccines. Bavarian Nordic is a global leader in smallpox vaccines and has been a prolific supplier to the Government of the U.S of a non-replicating smallpox vaccine, authorized by the Food and Drug Administration, also for the protection against monkeypox. The vaccine is also authorized in order to protect against smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. The company's commercial product portfolio furthermore contains the top-most vaccines against tick-borne encephalitis and rabies. Using their live virus vaccine program, MVA-BN, they have established a diverse portfolio of proprietary and partnered product candidates designed in order to save and improve lives by unfastening the power of the defense system, including an Ebola vaccine, licensed to the Janssen Pharma Companies of Johnson & Johnson. Bavarian Nordic is also committed to the development of a next-generation vaccine for COVID-19.

Factors Associated with Adherence to Oral Kahler's Disease Therapy

Shortfall of adherence to cancer treatment comprising oral therapies can contribute to poor treatment findings, and researchers carried out a study to probe factors that may be associated with lack of adherence to oral agents. 

Wilbur Rutter, Ph.D., PharmD, of CVS Health in Lincoln, Rhode Island, and colleagues presented the study’s outcomes in a poster at the American Society of Clinical Oncology Annual Meeting 2022.

In this carried out study, Dr. Rutter and colleagues did a retrospective review of records from patients with newly diagnosed Kahler's Disease also named multiple myeloma (MM) who were being treated with the help of oral agents during the time span of 01/09/2016, through 01/09/2020. 

Adherence to therapy was the finding of interest, which was elaborated as having an annual medicine possession ratio of 0.8-1.2. A socioeconomic status (SES) composite index (created by researchers), was developed from data acquired at the zip-code level.

Researchers did a multivariable regression investigation of adherence with factors including the socioeconomic status-index and demographic deets.

On behalf of the socioeconomic status index, patients were grouped as Very Low, Low, Medium, High, and Very High groups. It reflected rising levels of zip code-based median household income as socioeconomic status-index values rose from very low to very high. It also aligned with US CDC Social Vulnerability Index (SVI) scores, reflecting greater vulnerability with minor socioeconomic status.

Carried out study included a total of 6602 patients, 64.5 percent of whom were adherent. Adherent patients were compared with non-adherent patients. 

The multivariable evaluation suggested several evaluated factors demonstrated significant, independent link-ups with adherence. Regarding adherence based on socioeconomic status-index scores, the researchers considered patients with a very low socioeconomic status index to show a significantly lower rate of adherence than seen in patients having a very high socioeconomic status index.

The increasing age was related to greater adherence, although polypharmacy was related to less adherence.

Compared with lacking polypharmacy, patients with mild polypharmacy were less likely to be adherent. Moderate polypharmacy was also related to nonadherence, as was significantly polypharmacy.

Conclusion: Researchers concluded there were not any specific relationships with adherence across maximum socioeconomic status indexes, but that patients in Very Low socioeconomic status zip codes demonstrated less adherence than patients in Very High socioeconomic status zip codes did. Polypharmacy and younger age were other factors researchers considered linked to worse adherence.

Atracurium Besylate: Precautions and Warnings

 

Atracurium Besylate is a nondepolarizing neuromuscular blocker, also known as an immune suppressor. Atracurium Besylate is used in the treatment of lymphoma, multiple myeloma, leukaemia, ovarian cancer, breast cancer, small cell lung cancer, neuroblastoma, and sarcoma. Atracurium Besylate is supplied in 25 mg in 2.5ml single-use vials to administer intravenously. One should read the warnings and precautions associated with Atracurium Besylate, such as: 

Atracurium Besylate has been associated with residual paralysis. Patients with neuromuscular diseases and carcinomatosis may be at higher risk of residual paralysis. To prevent complications resulting from Atracurium Besylate-associated residual paralysis, extubation is recommended only after the patient has recovered sufficiently from neuromuscular blockade.

Serious adverse reactions, including “gasping syndrome”, can happen in neonates and infants treated with benzyl alcohol-preserved drugs, including Atracurium Besylate. When prescribing the doses of Atracurium Besylate vials in infants, consider the combined daily metabolic load of benzyl alcohol from all sources, including Atracurium Besylate and other drugs containing benzyl alcohol. 

Patients treated with Atracurium Besylate with renal or hepatic impairment might have higher metabolite concentrations than patients with normal renal and hepatic function. The level of neuromuscular blockade during long-term Atracurium Besylate administration should be monitored with a nerve stimulator to titrate the drug Atracurium Besylate administration to the patients’ needs and limit exposure to toxic metabolites.

There are reports of severe hypersensitivity reactions, including fatal and life-threatening anaphylactic reactions after administration of Atracurium Besylate injection. Due to the potential severity of such reactions, one should take appropriate precautions, such as the immediate availability of appropriate emergency treatment. 

Administration of Atracurium Besylate results in paralysis, leading to respiratory arrest and death, a progression that may likely happen in a patient for whom it is not intended. One should confirm the proper selection of the intended product and avoid confusion with other injectable solutions in critical care and other clinical settings.

Neuromuscular blockade in the conscious patient could lead to distress. Use Atracurium Besylate in the presence of appropriate sedation or general anaesthesia. One should monitor patients to ensure that the level of anaesthesia is adequate. 

Certain drugs might enhance the neuromuscular blocking action of Atracurium Besylate, including inhalational anaesthetics, antibiotics, magnesium salts, lithium, local anaesthetics, procainamide, and quinidine. One should use peripheral nerve stimulation and monitor the clinical signs of neuromuscular blockade to determine the adequacy of the level of neuromuscular blockade and the need to adjust the Atracurium Besylate dosage.

  

Note: All information mentioned in this article is provided just for informational, educational, and referential purposes only.

Abciximab: A New Antiaggregant For Angioplasty

Abciximab is licensed as the Fab fragment of the chimeric human-murine monoclonal antibody 7E3. It is involved in binding to the glycoprotein (GP) Ilb/Illa receptor of the human platelets and inhibits platelet aggregation. Abciximab is also involved in binding to the vitronectin receptor typically found on the platelets and vessel wall endothelial and smooth muscle cells. This medicinal product is prescribed when you undergo an operation known as angioplasty for the following purposes: 

• Abciximab is prescribed (along with heparin and aspirin) for the prevention of the formation of blood clots in the heart while on or after an angioplasty operation. 
• Abciximab is also prescribed (along with heparin and aspirin) to reduce the short term risk of getting a heart attack prior to an angioplasty operation, which is planned to take place within the next 1-month. This is for those who have chest pain due to low blood supply to the heart (unstable angina) and have not responded to the usual therapy.

What Abciximab Does?

As an active ingredient, abciximab is a fragment of murine or human chimeric monoclonal antibody, which are specific proteins that recognize and bind to other unique proteins. Abciximab falls under the group of medications known as antithrombotics and binds to platelets in the blood in order to help prevent blood clots. 

Posology and Method of Administration

Abciximab is introduced for intravenous administration in adult patients. It should only be used in conjunction with extensive health specialist care. In addition, there must be the existence of laboratory tests of hematology function as well as facilities for administration of blood products.

The recommended dose of abciximab injection is a 0.25 mg/kg intravenous bolus promptly followed by a 0.125 µg/kg/min (to a maximum of 10 µg/min) continuous intravenous infusion.

For the stabilization of unstable angina patients, the bolus dose of abciximab followed by the infusion needs to be initiated up to 24 hours before the possible intervention and concluded 12 hours following the intervention.

In order to prevent ischemic cardiac complications in such patients who are undergoing percutaneous coronary intervention, and are not currently receiving a Abciximab infusion, the bolus needs to be administered 10 to 60 minutes before intervention followed by the infusion for 12 hours.

Adverse Effects due to Abciximab

The most commonly reported adverse effects due to abciximab injection are hypotension, injection site pain, chest pain, abdominal pain, vomiting, minor hemorrhage, nausea, gross hematuria, and backache.

Some rare but severe side effects due to abciximab may include anaphylaxis, major hemorrhage (cerebrovascular, pulmonary), thrombocytopenia, and non-hemorrhagic cerebrovascular accident.

The administration of Abciximab is not associated with an increased risk of bleeding in patients undergoing CABG treatment.

Warnings And Precautions

Therapy with abciximab may be responsible for increasing the risk of bleeding, particularly in case you are receiving other medicines for preventing your blood from clotting (blood thinners). Cases of death because of bleeding have been noted with the administration of Abciximab. Prior to starting treatment with Abciximab discuss with your health specialist:

• In case you are taking blood-thinner or any other drugs that affect blood clotting or blood platelets. 
• In case you have previously received abciximab, since this could be linked with increased risk of reduction in blood platelets or allergic reactions (hypersensitivity). 
• In case you are pregnant or want to become pregnant or are breast-feeding. Your healthcare specialist can discuss with you the possible risks and benefits involved. 
• In case you think that you fit into any of the above-mentioned categories, it is crucial that you discuss it with your health specialist

Interactions with Abciximab

Medicines that may interact with Abciximab 10 MG /5ML include: Blood-thinners, or any other medications that are responsible for affecting blood clotting (anticoagulants) or blood platelets (‘antiplatelet drugs). It is quite necessary that you inform your health specialist if thrombolytic agents have been given to unblock your arteries. Being given Abciximab injection 10mg/5mL along with these medications may be responsible for putting you at risk of increased bleeding.

Storage and Availability

Currently, Abciximab is a prescription-only medication typically available as an intravenous (IV) solution. Vials of Abciximab should be stored at 2°C to 8°C (36°F to 46°F). Neither freeze nor shake the vials. Never use it beyond the date of expiry. Unused portions left in the vial should be discarded. In India, the abciximab price is absolutely reasonable. In order to procure this medicinal product at the most reasonable price range, one can directly get in touch with us through TOLL-FREE: 1800-889-1064. We're authentically established WHO-GDP and ISO certified pharmaceutical wholesaler/supplier/distributor, based in India. 

NOTE: Deets mentioned in this article about "Abciximab: A New Antiaggregant Used in Angioplasty" is for informational or educational purposes only, and does not substitute professional medical advice or consultations with health specialists.