All about comparator drug

Comparator drugs are also known as reference-listed drugs. These drugs have already been approved and have a license. Also, these drugs are already being used in the market to treat patients. Comparing new generic versions with reference-listed drugs shows the biochemical similarity, having the same active ingredient and effect on patients. In its regulatory submissions, a drug company seeks approval to market a generic equivalent and refers to the Reference Listed Drug. 

There is heavy demand for alternatives to generic medicines in the pharmaceutical industry. Heavy demand for alternative generic medicines results in pressure on pharmaceutical companies to frame robust strategies for selecting a Comparator drug and then sourcing and maintaining an uninterrupted supply of that drug to all trial sites in a cost-effective manner. 

The top 10 pharmaceutical companies together spend more than $20 million every year on comparator sourcing. Innovators or drug producers, wholesalers, and local distributors can carry out direct comparator sourcing. 

Participation of Ikris in pharma industry as comparator drug sourcing

Ikris Pharma Network is an internationally acclaimed pharmaceutical wholesaler and service company. It has specialization in sourcing Comparator drug(s)/ innovator samples from worldwide (countries like India, USA, Europe, Canada, Australia, New Zealand, Korea, Japan, and Latin America). Ikris specifically is a one-stop source for all your requirements of innovator samples (single batch/multiple batches of specific quantities) for clinical trials as well as bioequivalence studies.

We have an internationally established supplying network that helps us procure, store, and provide the products from all the major pharmaceutical manufacturers and authorized distribution channels to and from any locations in the world, specific product sets in a bit huge volumes. We only work with approved sources and validated supply chains.

We have expertise in cold chain shipping and international customs requirements, which helps us ensure that the temperature-sensitive study drugs arrive within the required temperature range at the clinical trial facilities. We use reliable transportation that caters to cold, ambient, and everyday storage and delivery requirements. 

We provide regular updates and advise of product shortages or manufacturer delays allowing you to stay one step ahead and plan your study accordingly. 

We work with the best logistics and courier partners, which enable us to efficiently get your Comparator drug supply to you on or ahead of time.

Our Comparator drug sourcing service included:

• Clinical Trial Services 
• Investigational Medical Products and Comparators
• Rescue medication
• Co-medication
• Analytical samples

Atracurium Besylate- All you need to know about

Atracurium Besylate is also known as Atracurium Besilate. It is used with other medications to provide skeletal muscle relaxation during surgery or mechanical ventilation. Atracurium Besylate is an intermediate duration, non-depolarizing, skeletal muscle relaxant for intravenous administration. It is given via intravenous infusion. The standard strength of Atracurium Besylate is 25 mg. 

Dosage and administration 

Do not administer an Atracurium ampoule before unconsciousness has been induced to avoid distress to the patient. Do not mix Atracurium Besylate in the same syringe, or administer it simultaneously through the same needle, with alkaline solutions, e.g., barbiturate solutions. Administer Atracurium Besylate intravenously. Do not give Atracurium through intramuscular administration because such administration of the medicine may result in tissue irritation. The use of a peripheral nerve stimulator would facilitate Atracurium with other neuromuscular blocking agents, minimizing the possibility of an overdose and assisting in the evaluation of recovery.

The general dosage for adults

A dose of Atracurium infusion of 0.4 to 0.5 mg/kg is the initial recommended dose for most patients. Good conditions for non-emergency intubation can be expected in 2-2.5 minutes in most patients with this dose, with maximum neuromuscular block achieved approximately 3-5 minutes after injecting the medicine. Underbalanced anaesthesia, clinically required neuromuscular block generally lasts 20 to 35.

Atracurium Besylate is intensified by isoflurane or enflurane anaesthesia. The same initial dose of the medicine may use 0.4 to 0.5 mg/kg for intubation before administering these inhalation agents. However, if Atracurium is first administered under the steady-state of isoflurane or enflurane, reduce the initial dose of Atracurium besilate by approximately one third, i.e., to 0.25-0.35 mg/kg. With halothane, which has only a marginal potentiating effect on the medicine, consider the smaller dosage reductions.

Recommended doses of the medicine are 0.08 to 0.10 mg for maintenance of neuromuscular block during prolonged surgeries. Generally, the first maintenance dose required is 20 to 45 minutes after the initial Atracurium infusion, but clinical criteria should determine the need for maintenance doses. 

The general dosage for children

There is no requirement for adjustments of doses of Atracurium Besylate pediatric patients two years of age or older. A dose of 0.3-0.4 mg/kg is recommended as the initial dose for infants under halothane anaesthesia. In infants and children than in adults. Maintenance doses might be required with slightly greater frequency.

Dosage In special cases

An initial dose of the medicine of 0.3 to 0.4 mg/kg is recommended for adults, adolescents, children with significant cardiovascular disease. And adults, adolescents, children with any history (e.g. asthma), suggesting a greater risk of histamine release, give it slowly or in divided doses for 1 minute.

Overdosage

If an overdose happens, the doctor will monitor the patient for symptoms or worsening signs. One can minimize the chances of an overdose by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of the medicine can be expected to produce enhanced effects.

Atracurium mechanism of action

The salt Atracurium Besylate is a nondepolarizing skeletal muscle relaxant. Such nondepolarizing agents oppose the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end plate. The antagonism is inhibited, and the neuromuscular block is reversed by acetylcholinesterase inhibitors like neostigmine, pyridostigmine and edrophonium.

Atracurium can be used if muscle twitch response to peripheral nerve stimulation is monitored to assess the degree of relaxation of the muscle. 

The duration of neuromuscular block produced by this medicine is approx one-third to one-half of the block by d-tubocurarine, metocurine, and pancuronium at initially equal doses. As with other nondepolarizing neuromuscular blockers, the onset of paralysis decreases and the duration of maximum effect increases with increasing atracurium doses.   

Precautions

Before Atracurium infusion, ask the patient about any medical history or anaphylactic reactions. Moreover, the healthcare professionals should acknowledge the patient about the after-effects of having Atracurium infusion. 

Although Atracurium is a less potent histamine releaser than d-tubocurarine or metocurine, one must consider the possibility of substantial histamine release in sensitive individuals.

One should take necessary precautions while administering Atracurium to patients in whom substantial histamine release will be especially hazardous, e.g., patients with clinically significant cardiovascular disease. And patients with any history like severe anaphylactoid reactions suggesting a greater risk of histamine release. In such patients, the initial recommended dose is lower (0.3 to 0.4 mg/kg) than other patients. It should be administered slowly or in divided doses over one minute. 

Side effects of Atracurium

The common side effects of Atracurium Besylate are allergic reactions, itching, low blood pressure, skin redness, reactions at the injection site, etc. Medicine's severe side effects are  Severe anaphylactic reactions, paralysis, respiratory arrest, etc.

Price of Atracurium in India

Atracurium price offered by innovators or manufacturers is high as compared to the price offered by suppliers. In India, rare medicines like these are readily available and are cheap. Ikris Pharma Network is one such certified supplier in India delivering medicines and services in India and abroad. 

Treosulfan crystalline powder

Treosulfan is the medication given to people before a bone marrow transplant from a donor known as allogeneic hematopoietic stem cell transplantation. Trecondi is the trade name of Treosulfan. It is given in combination with another drug called fludarabine. It comes in the form of crystalline powder for solution for infusion of 5 gm strength.

Usage of Treosulfan 5 gm

Treosulfan is used before allogeneic hematopoietic stem cell transplantation (alloHSCT). It is used as a 'conditioning' treatment to clear the bone marrow and make space for the transplanted bone marrow cells that can produce healthy blood cells. Healthcare professionals recommend it to adults, children, and old people with severe disorders having allogeneic hematopoietic stem cell transplantation. 

Administration and Dosage of Treosulfan 5 g

1. Patients with malignant disease

Treosulfan is given in combination with fludarabine.

The recommended doses and schedule of administration are:

Treosulfan 10 g body surface area (BSA) per day as a two-hour intravenous infusion, given three consecutive days before stem cell infusion. The total treosulfan dose is 30 g.

Administer Fludarabine 30 mg BSA per day for half an hour for intravenous infusion, given five consecutive days before stem cell infusion. The total fludarabine dose is 150 mg. Administer Treosulfan before fludarabine on three consecutive days. 

2. Patients having non-malignant disease. 

Treosulfan can be given in combination with fludarabine with or without Thiotepa Injection. 

The recommended doses and schedule of administration are:

Treosulfan 14 g body surface area (BSA) per day as a two-hour intravenous infusion, given three consecutive days before stem cell infusion. The total treosulfan dose is 42 g.

Fludarabine 30 mg BSA per day as a half an hour intravenous infusion, given five consecutive days before stem cell infusion. The total fludarabine dose is 150 mg

Treosulfan should be administered before fludarabine.

Thiotepa 5 mg twice a day, given as two intravenous infusions over 2–4 hours on the second day before stem cell infusion. 

3. Elderly population

There is no requirement for the dose adjustment in any subset for elderly patients. 

4. Renal and hepatic impairment 

No dose adjustment is required for mild or moderate impairment, but Treosulfan is contraindicated in patients with severe disorders. 

5. Pediatric population

Treosulfan 5 g injection is given in combination with fludarabine with or without thiotepa.

The recommended doses and schedule of administration are:

Treosulfan 10-14 g body surface area per day as a two-hour intravenous infusion, given three consecutive days before stem cell infusion. The total treosulfan dose is 30-42 g. The dose of Treosulfan is administered according to the body surface area of the patient.

Fludarabine 30 mg BSA per day as a half an hour intravenous infusion, given five consecutive days before stem cell infusion. The total fludarabine dose is 150 mg.

• Administer Treosulfan before the dosage of fludarabine.
• Thiotepa (intensified regimen 5 mg twice a day), given as two intravenous infusions over 2– 4 hours on the second day before stem cell infusion.

The safety and efficacy of Treosulfan medicine in children less than 1 month of age have not yet been established.

Precautions before administration

• The shelf-life of an unopened vial of Treosulfan is 5 years.
• Treosulfan is for intravenous infusion for two-hour.
• When handling Treosulfan, one should avoid inhalation, skin contact, or contact with mucous membranes. Keep pregnant women away from cytotoxics.
• Administration of the medicine should be performed using a safe technique to avoid extravasation. 

Side effects 

Treosulfan injection has common side effects such as infections, nausea, stomatitis (inflammation of the lining of the mouth), vomiting, diarrhea, and abdominal pain. Cardiac disorders, gastrointestinal disorders, nervous system disorders, blood and lymphatic system disorders, and many more are severe side effects of the medicine.

Overdose

There is no antidote for overdose of Treosulfan. One should take medicine according to the recommended dosage of the doctor. The principal toxic effect of Treosulfan is profound myeloablation and pancytopenia. Moreover, acidosis, skin toxicity, nausea, vomiting, and gastritis might occur. Healthcare professionals should monitor the patient regularly for worsening symptoms or any such symptoms. 

Cost of Treosulfan

It is seen that the price of medicine made by innovators is more costly than the other suppliers. In India, Treosulfan cost is reasonable the reason is multiple generic brands are available in India. The drug is easily available with the suppliers like Ikris Pharma Network- Pharmaceutical wholesale distributors in India, a trusted brand for delivering such medications in India and abroad at the best possible time.

Fulvestrant Guidance

Fulvestrant helps in treating hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression and HR-positive, HER2-negative advanced breast cancer in combination with palbociclib in women with disease progression after endocrine therapy. Fulvestrant is a selective estrogen receptor degrader (a type of drug which binds to the estrogen receptor). Faslodex is the trade name of Fulvestrant. The strength of the medicine is 250 mg.

Dosage and Administration

Fulvestrant injection is for intramuscular administration. For the proper dosage, the patient should seek a prescription prescribed by the doctor, administer the recommended dose of Fulvestrant 500 mg intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 ml injections, one in each buttock, on Days 1, 15, 29, and once in a month after that. Fulvestrant 250 mg is also given in combination with other drugs such as palbociclib, abemaciclib, or ribociclib. Administration instructions are as follows: 

1. Remove the glass syringe barrel from the tray and check that it is not damaged.
2. Remove the perforated patient record label from the syringe. 
3. Peel open the safety needle outer packaging. For complete SafetyGlide instructions, refer below to the "Directions for Use of SafetyGlide."
4. Break the white plastic cover seal on the syringe Luer connector to remove the cover with the attached rubber tip cap.
5. Twist to lock the needle to the Luer connector.
6. Remove needle sheath.
7. Remove excess gas from the syringe. 
8. Administer intramuscularly slowly in the buttock. 
9. Immediately activate the needle protection device upon withdrawal from the patient by pushing the lever arm completely forward until the needle tip is fully covered.
10. Visually confirm that the lever arm has fully advanced and the needle tip is covered. If unable to activate, discard immediately into an approved sharps collector. 
11. Repeat steps from 1 to 10 for the second syringe. 

Side Effects  

Fulvestrant 250 mg common side effects are; nausea, injection site reactions, weakness, and elevated transaminases (an indicator of liver dysfunction). Drug's severe side effects are urinary tract infections, hypersensitivity reactions, loss of appetite, headache, blood clots in veins, hot flushes, vomiting, diarrhea, elevated bilirubin, rashes, and intense back pain. 

Precautions

It advises females of reproductive potential of the potential risk to a fetus and uses effective contraception during treatment with inj Fulvestrant and for one year after the last dose. Doctors advise using it with caution in patients with bleeding diathesis, thrombocytopenia, or anticoagulant use. Before taking this medicine, one should go for counseling and run a check-up for medical complications in the future.

Fulvestrant injection price

It is seen that the price of Fulvestrant Injection made by innovators is more costly than the other suppliers. In India, Fulvestrant injection comes at reasonable prices. The drug is readily available with the suppliers like Ikris Pharma Network, a trusted brand for supplying such rare medications in India and abroad ASAP.

Apremilast 30 mg price and availability

Apremilast is advised for patients who have psoriatic arthritis and psoriasis. Apremilast is selling under the trade name of Otezla. Apremilast plays the role of a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4) and resists the TNF-alpha production from human rheumatoid synovial cells. It has been proven beneficial in some immune system-related inflammatory diseases. 

Apremilast comes in tablet forms for oral administration. Apremilast 30 mg dose after the 5-day titration, recommended is 30 mg twice daily taken orally starting on Day 6. Some of the common side effects of taking Apremilast are nausea, diarrhea, headache, sneezing, sore throat, etc. Some of the severe side effects are unexplained weight loss, depression, allergic reactions, severe diarrhea, severe stomach ache.

There is an observation that Apremilast cost is much lower in India than in any other country it is due to multiple generic versions of apremilast is available in India. Ikris Pharma Network is one of the branded and trusted names in the supply of such rare medicines around the world. Ikris Pharma Network provides effective services in a short time span. Ikris is a WHO-GDP certified International Pharmaceutical wholesaler. For more details you can also contact on TOLL FREE- 1800-889-1064

Note:- Always carry a doctor prescription while buying this medication online or offline.

Medical uses of ATGAM Injection

ATGAM is introduced to manage the allograft rejection in the recipients of renal transplant; when used along with conventional therapy at the moment of rejection this agent increases the frequency of the resolution of the acute rejection episode. 

ATGAM is approved to treat moderate/severe aplastic anemia in recipients unsuitable for the bone marrow transplantation.

The usefulness of atgam injection has not been shown in recipients with aplastic anemia who are suitable candidates for bone marrow transplantation or in recipients with aplastic anemia secondary to neoplastic disease, Fanconi's syndrome, storage disease, myelofibrosis, or in patients known to have been exposed to radiation or myelotoxic agents.

Approval: The ATGAM injection is approved in the US (United States):

• In order to manage moderate/severe aplastic anemia (a blood disorder that damages stem cells).

• In order to prevent the body from rejecting a kidney transplant.

Dosage Form: ATGAM comes in the form of injection. It is intended for intravenous use only with concomitant immunosuppressants. While repeat courses of ATGAM, observe the recipients for signs of allergic reactions. 

The recommended dose of ATG injection for Renal Allograft Recipients is 10 to 15 mg per kg daily administered intravenously for 2 weeks. The supplementary alternate day therapy up to a total of 21 doses can be administered.

The recommended dose for Aplastic Anemia (Moderate to Severe) is 10 to 20 mg per kg daily administered intravenously for 8 to 14 days. The supplementary alternate day therapy up to a total of twenty one doses can be given. Because thrombocytopenia can be related with the use of ATGAM, patients with this therapy for their aplastic anemia may require prophylactic platelet transfusions in order to maintain the count of platelets at the clinically acceptable levels.

Side Effects: Side effects of ATGAM are usually mild and not life threatening. The most commonly reported side effects include chills, fever, nausea, vomiting, diarrhea, dizziness, hives and headache. These side effects due to ATGAM usually go away following treatment.

Cost: The atgam injection price in India may vary depending on the wholesaler or pharmacy and of course the brand you choose. The cost of atgam injection usually depends on the branded to non-branded drugs and certain other factors. 

Medical uses of Octreotide Injection

Octreotide acetate is used for reducing blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who haven't had adequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.

The octreotide injection is also used for the symptomatic treatment of patients with metastatic carcinoid tumors where this agent is believed to suppress or block the severe diarrhea and flushing episodes associated with the disease.

Octreotide acetate is used in order to treat the profuse watery diarrhea associated with the VIP-secreting tumors. 

Approval: As an octapeptide, the medication octreotide mimics the natural somatostatin pharmacologically, though it is an absolutely potent inhibitor of growth hormone, glucagon, and insulin in comparison to the natural hormone. 

In 1979 Octreotide was initially synthesized by Wilfried Bauer, and binds predominantly to the somatostatin receptors SSTR2 & SSTR5. In 1988 Octreotide was approved for use in the United States.

Dosage Form: Octreotide comes in the form of injection generically and under the brand name Sandostatin. Always use octreotide 100 mcg as per words by a healthcare professional. Depending on the complication being treated, Octreotide is administered by subcutaneous (under the skin) injection or intravenous (into a vein) infusion. In case patients have liver cirrhosis (chronic liver disease), their doctor may need to adjust their maintenance dose. A doctor will explain to a patient how to inject Octreotide injection under the skin, but infusion into a vein must always be performed by a healthcare practitioner.

Side Effects: Side effects of octreotide are usually mild and not life threatening. The commonly reported side effects may include vomiting, headache, hypothyroidism, cardiac conduction changes, diarrhoea, constipation, gallstones, reduction of insulin release, slow heart rate, nausea, injection site reactions, skin reactions and cramps. 

Cost: The octreotide injection price in India may vary depending on the wholesaler or pharmacy and of course the brand you choose. The cost of octreotide 0.05 mg is around Rs. 380 for a supply of vial of 1 injection.