Foscarnet Sodium: All you need to know

Foscavir (Foscarnet Sodium) is an organic analogue of inorganic pyrophosphate that inhibits the replication of herpes viruses in vitro, including cytomegalovirus (CMV) and herpes simplex virus types 1 and 2 (HSV1 and HSV-2). Healthcare professionals recommend using this drug in treating patients with CMV (Cytomegalovirus) retinitis in those with acquired immunodeficiency syndrome (AIDS) and acyclovir-resistant herpes simplex virus (HSV) infections in immunocompromised patients. 

Warning and Precautions

 

• Contact of the drug with eyes and skin may be responsible for causing a burning sensation and local irritation. In case of accidental contact, the exposed area must be rinsed immediately with the help of cold water.

•  Healthcare professionals do not recommend Foscarnet injection for use in those patients who are undergoing haemodialysis as dosage guidelines have not been established.

•  One should use foscarnet with caution in those with reduced renal function. Since renal function impairment might occur during foscarnet uses, one should monitor serum creatinine every second day during induction therapy and once a week during maintenance treatment. 

•  To scale down the risk of renal function impairment, one should maintain adequate hydration in all patients. The renal function of those with renal disease or taking concomitant treatment with other nephrotoxic medicines should be closely assessed. 

•  Due to the existence of sodium in the Foscarnet drug, one should avoid its use when a saline load is difficult to be tolerated. All the respective patients should also consider this on a controlled sodium diet. 

•  One should take specific caution with reduced calcium levels before treatment and those with other drugs known to influence serum calcium levels. Electrolytes, mainly magnesium and calcium, should be evaluated prior to and during Foscarnet Sodium injection, 24mg/mL in 250 mL therapy and deficiencies corrected.

•  One should monitor patients precisely with any known existing prolongation of cardiac conduction intervals, mainly QTc, in those with electrolyte disturbances, or bradycardia, as well as those with underlying cardiac diseases due to increased probability of ventricular arrhythmia. 

•  Seizures related to alterations in plasma minerals and electrolytes have been linked with foscarnet treatment. Status epilepticus may occur. Therefore, one should carefully monitor patients for such changes and their potential sequelae. Mineral and electrolyte supplementation can be used.

• The medicine Foscarnet might be excreted in high concentrations in the urine and might be responsible for genital irritation and ulceration. Precisely attention to personal hygiene is required to prevent irritation and ulceration, and cleaning of the genital area after each micturition is required. 

•  Since no clinical experience or investigational findings are available, Forscanet Sodium 24mg/mL in 250 mL should not be prescribed to pregnant women or to women who are lactating.

•  Women capable of childbearing must use appropriate and effective contraception methods during Foscarnet Sodium therapy. Men treated with this medicine should not have a child for 6 months after treatment.

Side-effects

There are several side-effects of Foscarnet Sodium are:

• Fever

•  Flu-like symptoms

•  Chest pain

•  Headache

•  Back pain

•  Vomiting

•  Nausea

•  Diarrhoea

Future of contract manufacturing in Pharmaceutical

 India has a strong presence in the pharmaceutical industry’s CDMO (contract development and manufacturing organization) segment. Since India offers world-class quality pharma products at a low price, contract manufacturing is among the fastest expanding areas of the pharmaceutical business. Contract manufacturing for pharmaceuticals requires innovative technologies to keep up with changing market trends. Today, the emphasis is on building resilience in supply chains with multiple facilities across locations to meet the rising and unprecedented demand. According to MarketsandMarkets, the worldwide pharmaceutical contract development and manufacturing market is expected to grow at a CAGR of 7.7%, from USD 100.7 billion in 2020 to USD 146.1 billion in 2025.

The ever-expanding demand for generics increased pharmaceutical R&D spending, and CDMO investments in sophisticated production methods are some of the factors driving the growth of CDMOs today.  

As a contract development and manufacturing organization (CDMO) supporting key players in the pharmaceutical industry, Ikris Pharma Network (IPN) has prepared for the future by implementing this guidance. Our new multi-product, large-scale fill/finish facility was designed from the ground up with safety, quality, and flexibility top of our minds. By investing in best-in-class equipment supported by the latest technology and designing a facility with superior environmental, health and safety, engineering, and cross-contamination controls, Ikris can support the varied needs of current and prospective clients now and in the future.

As the entire pharmaceutical manufacturing industry continues to shoulder immense pressure to be more cost-effective and reduce timelines for life-saving medicines, dynamic multi-product facilities, and equipment design will only grow in prominence. Flexible equipment supported by modern facility design, along with proven processes and controls, reduce risk and can ultimately help eliminate the threat of cross-contamination. With demand growing daily, pharmaceutical companies should take decisive action today to better prepare for tomorrow by investing significant capital in facility and equipment design modernization.

Trifluridine Tipiracil: A New Oral Therapy Approved for Patients with Metastatic Colorectal Cancer

Fast Facts: 

• Colon and rectal cancers combined are the 3'rd most commonly occurred cancers in men and women.
• Around 1 in 20 Americans will be diagnosed with colon cancer or rectal cancer in his/her lifetime.

What is Trifluridine Tipiracil?

Trifluridine Tipiracil tablets are a prescription medication for refractory Metastatic Colorectal Cancer. It is supplied as an oral tablet, which means it is administered by mouth. This medicinal product is a prescription chemotherapy tablet that is made up of two parts. This therapy offers you a chance to continue treating your cancer. It may help you live longer and resist or inhibit the progression of your cancer for a period of time.

The medication trifluridine tipiracil was evaluated in a clinical trial of 800 populations. 

• Half of the populations treated with trifluridine tipiracil therapy were still alive at 7.1 months and half of the populations who received placebo were still alive at 5.3 months 
• Worsening of the condition or death occurred in 88% of patients treated with trifluridine tipiracil and 94% of patients who received placebo

The trifluridine tipiracil tablet comes in 2 strengths: 15mg and 20mg. A health specialist may prescribe both strengths for your prescribed dose.

Who is Trifluridine Tipiracil For:

This medicinal product is recommended for treating those with colon or rectal cancer that has spread to other portions of the body and who have earlier treated with or cannot take certain chemotherapy agents. Those previous agents may include

• Anti-VEGF biological therapy, or VEGF inhibitors: Such as bevacizumab or Aflibercept. 
• Anti-EGFR therapy, or EGFR inhibitors (if you have the KRAS wild type gene): Such as cetuximab; or panitumumab. 
• Fluoropyrimidine: Such as 5-FU, also known qs 5-fluorouracil.
• Oxaliplatin-based treatment: Such as 5-FU, leucovorin, and oxaliplatin; capecitabine and oxaliplatin; or oxaliplatin. 
• Irinotecan-based treatment: Such as 5-FU, leucovorin, and irinotecan; capecitabine and irinotecan; or irinotecan. 

In case you aren’t sure what treatments you’ve had in the past, ask your health specialist. 

Mechanism of Action of Trifluridine Tipiracil

Tablets of trifluridine tipiracil work in a different way than other therapies for colon or rectal cancer. That is why it may still help individuals for whom other therapies have stopped working. This medicinal product is the first FDA-approved combination tablet for the treatment of patients with refractory Metastatic Colorectal Cancer. It is an oral chemotherapy that is two medications in one. With the two medicines working together, trifluridine and tipiracil may help inhibit cancer cell growth. 

How can Trifluridine Tipiracil Help Me

Trifluridine Tipiracil has been proven to allow some individuals with refractory Metastatic Colorectal Cancer to live longer. It has also been proven to slow or stop the growth of disease for a period of time. Like all medicines approved by the FDA, trifluridine tipiracil 20 mg/8.19mg was evaluated in clinical trials. The clinical trial in which this medicine was studied included 800 populations.

Some individuals in the trial lived longer than others. It is hard to predict exactly how much this agent may help extend a particular individual’s life, because everyone is different.

Most Important Information About Trifluridine Tipiracil

A respective healthcare specialist should assess blood cell counts prior to treatment with trifluridine and tipiracil pills, at day 15 of each treatment cycle, and as required.

• Reduced blood counts are common with therapy and can sometimes be severe and life-threatening. Therapy can be responsible for causing a reduction in WBCs, RBCs, and platelets. Reduced WBCs can make you more likely to get severe infections that might lead to death. A health specialist may decrease or stop the dose if you have low WBC or low platelet counts. 
• Inform your health specialist promptly in case you develop any signs/symptoms of infection such as fever, chills, or body aches. 

Most common side effects due to Trifluridine Tipiracil: Almost all patients treated with trifluridine tipiracil 15mg/6.14mg experience side effects at some time. Some commonly reported side effects you may experience include:

• Vomiting
• Diarrhea
• Abdominal pain
• Fever
• Tiredness
• Nausea
• Decreased appetite

Inform your health specialist in case you have nausea, vomiting, or diarrhea that is severe or persistent. Note that, these are not all of the possible side effects of this medicinal product.

Serious side effects due to Trifluridine Tipiracil: This drug may also be responsible for causing serious side effects, including:

Low blood counts: Low blood counts are a bit common with Trifluridine Tipiracil treatment and can sometimes be severe and life-threatening. The medication can cause a reduction in white blood cells (WBCs), red blood cells (RBCs), and platelets. Low white blood cells (WBCs) can make you more prone to catch serious infections that could lead to death. A health specialist should do blood tests prior to Trifluridine Tipiracil therapy, at day 15 during therapy with this medicine, and as needed to assess the blood cell counts. A health specialist may reduce your dose of Trifluridine Tipiracil or stop it in case you have low white blood cell (WBCs) or platelet counts.

Note: Let your health specialist know right away in case you get any of the following signs/symptoms of infection throughout your treatment with Trifluridine Tipiracil: chills, body aches, or fever.

How to Take Trifluridine Tipiracil?

Proposed dosage of trifluridine and tipiracil pills are taken twice a day, after you eat breakfast and dinner (promptly after or up to 1 hour after). The type of food typically does not matter. Your trifluridine and tipiracil dose is determined on behalf of your body surface area (BSA). This depends on the height and weight. The higher your body surface area, the higher your dose will be. In case you have any query regarding BSA or dose, ask your health specialist. 

Supplied in 2 strengths: 15-mg and 20-mg tablets, take your dosage after morning and evening meals for 5 days a week, and then rest for a couple of days. This goes on for two weeks. Then you will not take this medicine for two weeks (14 days). That is one cycle. 

This is repeated for as long as your health specialist says. Always follow your health specialist’s directions carefully.

Importance of taking Trifluridine Tipiracil after morning and evening meals: The trifluridine tipiracil may cause a reduction WBCs. Taking this medicine after morning and evening meals may help scale down this effect. This is crucial because a low WBC count can make you a bit more prone to infection. The type of food you consider does not affect trifluridine and tipiracil. Just be sure to take your trifluridine tipiracil doses promptly after or up to 1 hour following meals.

Certain Things to Keep in Mind About Taking Trifluridine Tipiracil:

• In order to procure this medicine, always get in touch with a pharmaceutical wholesaler or supplier or distributor that holds certain authentic certification such as WHO-GDP and ISO. 
• The trifluridine tipiracil price is reasonably very less due to the availability of generic and innovator brands. Generic versions tend to cost less than their innovator alternatives. 
• Store the tableta of trifluridine tipiracil at room temperature between 68°F and 77°F (20°C to 25°C).
• Don’t store this medicinal product with other medicines. Keep it in its own container.
• In case you store your pills outside of the original container, any unused tablets should be disposed of after 30 days.
• Wash your hands once you handle pills. Even though it is a pill, it is still chemotherapy.
• Note that there is a packet inside the bottle that helps absorb moisture. Never swallow this material.

NOTE: Deets mentioned in this article is for informational or educational purposes only, and does not substitute professional medical advice or consultations with health specialists.

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.