Bosutinib Newbury
Tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia (CML)
Quick Facts: Bosutinib Newbury
Key Takeaways About Bosutinib Newbury
- Targeted cancer therapy: Bosutinib Newbury specifically blocks the BCR-ABL protein that drives chronic myeloid leukemia, offering targeted treatment with fewer off-target effects than older chemotherapies
- Take with food: Always take Bosutinib Newbury with a meal to improve absorption and reduce gastrointestinal side effects such as diarrhea and nausea
- Regular monitoring required: Blood counts, liver function, and kidney function must be checked regularly, especially during the first months of treatment
- Report diarrhea early: Diarrhea is the most common side effect and usually occurs in the first few weeks; early management with anti-diarrheal medication can prevent complications
- Drug interactions matter: Several common medications, including antacids and certain antibiotics, can affect how well bosutinib works – always inform your doctor of all medications you take
What Is Bosutinib Newbury and What Is It Used For?
Bosutinib Newbury is a tyrosine kinase inhibitor (TKI) used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adult patients. It belongs to a class of targeted cancer therapies that work by blocking the abnormal BCR-ABL protein responsible for the uncontrolled growth of white blood cells in CML.
Chronic myeloid leukemia (CML) is a type of blood cancer that originates in the bone marrow and leads to the overproduction of abnormal white blood cells. In over 95% of CML cases, the disease is driven by the Philadelphia chromosome – an abnormal chromosome formed when parts of chromosomes 9 and 22 swap places. This creates a fusion gene called BCR-ABL, which produces a constantly active tyrosine kinase enzyme that signals the bone marrow to produce too many white blood cells.
Bosutinib is a second-generation tyrosine kinase inhibitor that works as a dual Src/ABL kinase inhibitor. Unlike imatinib (the first TKI developed for CML), bosutinib has activity against both the BCR-ABL fusion protein and Src family kinases. This dual mechanism of action means it can be effective in patients who have developed resistance to or intolerance of earlier TKIs such as imatinib, dasatinib, or nilotinib.
Bosutinib Newbury is a generic formulation of bosutinib, approved by the European Medicines Agency (EMA). It contains the same active ingredient, in the same dosage form and strength, as the originator product Bosulif. Clinical studies and bioequivalence data have confirmed that Bosutinib Newbury has the same efficacy and safety profile as the reference product.
Approved indications
Bosutinib Newbury is indicated for:
- Newly diagnosed chronic-phase Ph+ CML in adult patients as first-line treatment
- Chronic-phase, accelerated-phase, or blast-phase Ph+ CML in adult patients previously treated with one or more tyrosine kinase inhibitors, and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options
The treatment of CML has been transformed since the introduction of TKIs in the early 2000s. Before TKIs, the five-year survival rate for CML was approximately 30%. Today, with appropriate TKI therapy, most patients achieve normal or near-normal life expectancy. Bosutinib represents an important option in the treatment armamentarium, particularly for patients who cannot tolerate or have stopped responding to other TKIs.
Bosutinib binds to and inhibits the BCR-ABL tyrosine kinase, the abnormal protein created by the Philadelphia chromosome. By blocking this protein, bosutinib stops the signals that tell leukemic cells to grow and divide. In laboratory studies, bosutinib has shown activity against 16 of 18 imatinib-resistant forms (mutations) of BCR-ABL, although it is not effective against the T315I mutation.
What Should You Know Before Taking Bosutinib Newbury?
Before starting Bosutinib Newbury, your doctor must verify your diagnosis of Ph+ CML and assess your liver function, kidney function, and blood counts. You should not take this medicine if you are allergic to bosutinib or have significant liver impairment. Tell your doctor about all medications, herbal supplements, and medical conditions before starting treatment.
Bosutinib Newbury is a potent prescription medication that should only be initiated and supervised by a physician experienced in the diagnosis and treatment of chronic myeloid leukemia. Before beginning treatment, a thorough medical evaluation is necessary to ensure the drug is appropriate for your specific situation and to establish baseline values for monitoring during treatment.
Contraindications
You must not take Bosutinib Newbury if you:
- Are allergic to bosutinib or any of the other ingredients in the tablet
- Have significant hepatic (liver) impairment that your doctor considers incompatible with treatment
Warnings and Precautions
Before starting treatment and throughout the course of therapy, your healthcare team should be aware of specific safety concerns associated with bosutinib. The following precautions are essential:
- Hepatotoxicity: Bosutinib can cause elevations in liver enzymes (ALT, AST) and, in rare cases, serious liver injury. Liver function tests should be performed before starting treatment and at least monthly for the first three months, then as clinically indicated. If significant elevations occur, treatment may need to be temporarily interrupted, the dose reduced, or the drug discontinued
- Diarrhea: This is the most common side effect, occurring in approximately 70–80% of patients in clinical trials. It is usually most severe during the first few weeks and typically resolves with supportive care. Anti-diarrheal agents such as loperamide should be available from the start of treatment. Severe or prolonged diarrhea requires dose interruption or reduction
- Myelosuppression: Bosutinib can suppress bone marrow function, leading to low blood counts (neutropenia, thrombocytopenia, anemia). Complete blood counts should be monitored weekly during the first month and then monthly, or as clinically indicated
- Fluid retention: Peripheral edema, pleural effusions, pericardial effusions, and pulmonary edema have been reported. Patients should be monitored for signs and symptoms of fluid retention such as unexpected rapid weight gain or swelling
- Cardiac events: Cases of QTc prolongation and cardiac failure have been reported. Patients with a history of cardiac disease or risk factors for QTc prolongation should be monitored closely
- Renal toxicity: Decreases in estimated glomerular filtration rate (eGFR) and cases of renal failure have been observed. Kidney function should be assessed at baseline and monitored during treatment
- Pancreatitis: Cases of pancreatitis, including severe cases, have been reported. Patients experiencing severe abdominal pain should be investigated promptly
Pregnancy and Breastfeeding
Bosutinib Newbury can cause harm to an unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least one month after the last dose. If you are pregnant, think you might be pregnant, or are planning to become pregnant, talk to your doctor immediately. Treatment should not be started during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding is not recommended during treatment with Bosutinib Newbury and for at least two weeks after the last dose. It is not known whether bosutinib passes into breast milk, but a risk to the nursing infant cannot be excluded.
Male patients should be aware that bosutinib may impair fertility. If you are concerned about fertility preservation, discuss this with your oncologist before starting treatment.
Do not stop taking Bosutinib Newbury or change your dose without consulting your doctor. Abruptly stopping TKI therapy can lead to rapid disease progression. Your doctor will determine the appropriate course of action based on your individual situation, including any dose adjustments that may be needed.
How Does Bosutinib Newbury Interact with Other Drugs?
Bosutinib Newbury can interact significantly with CYP3A4 inhibitors and inducers, proton pump inhibitors, and certain other medications. Strong CYP3A4 inhibitors increase bosutinib levels (risk of toxicity), while strong CYP3A4 inducers decrease levels (risk of reduced efficacy). Proton pump inhibitors can reduce bosutinib absorption.
Bosutinib is primarily metabolized by the liver enzyme CYP3A4, and its absorption is influenced by gastric pH. This means that other drugs affecting these pathways can significantly alter bosutinib blood levels, potentially leading to either increased toxicity or reduced therapeutic efficacy. It is critically important that you inform your oncologist of all medications, over-the-counter products, herbal supplements, and vitamins you are taking.
Major Interactions
| Drug / Drug Class | Effect on Bosutinib | Clinical Recommendation |
|---|---|---|
| Ketoconazole, itraconazole, voriconazole (strong CYP3A4 inhibitors) | Increases bosutinib blood levels significantly (up to 8-fold) | Avoid concomitant use. If unavoidable, consider bosutinib dose reduction and monitor closely |
| Ritonavir, cobicistat (strong CYP3A4 inhibitors / HIV protease inhibitors) | Significantly increased bosutinib exposure | Avoid concomitant use; seek alternative antiretroviral if possible |
| Rifampicin, rifabutin (strong CYP3A4 inducers) | Decreases bosutinib blood levels dramatically (up to 6-fold reduction) | Avoid concomitant use; bosutinib may become ineffective |
| Phenytoin, carbamazepine, phenobarbital (antiepileptics) | Significantly reduced bosutinib levels via CYP3A4 induction | Avoid if possible; consider alternative antiepileptic that does not induce CYP3A4 |
| St. John's Wort (herbal supplement) | Potent CYP3A4 inducer; unpredictable reduction in bosutinib levels | Must not be used during bosutinib treatment |
Moderate Interactions
| Drug / Drug Class | Effect on Bosutinib | Clinical Recommendation |
|---|---|---|
| Omeprazole, lansoprazole, esomeprazole (proton pump inhibitors) | Reduced bosutinib absorption due to increased gastric pH | Use short-acting antacids instead, separated from bosutinib by at least 2 hours |
| Ranitidine, famotidine (H2-receptor antagonists) | Moderately reduced bosutinib absorption | If needed, take H2-blocker more than 2 hours before or after bosutinib |
| Grapefruit, grapefruit juice | Inhibits CYP3A4 in the gut; may increase bosutinib levels | Avoid grapefruit and grapefruit juice during treatment |
| Erythromycin, clarithromycin (moderate CYP3A4 inhibitors) | Moderate increase in bosutinib levels | Use with caution; monitor for increased side effects and consider dose adjustment |
| Warfarin (anticoagulant) | Potential for altered warfarin metabolism | Monitor INR closely; consider alternative anticoagulant |
If you need antacids for heartburn or indigestion, take short-acting antacids (such as aluminum or magnesium hydroxide) at least 2 hours before or 2 hours after your bosutinib dose. Avoid proton pump inhibitors entirely if possible. Always discuss any new medication – including over-the-counter products – with your healthcare team.
What Is the Correct Dosage of Bosutinib Newbury?
The recommended starting dose of Bosutinib Newbury is 400 mg once daily for newly diagnosed CML, or 500 mg once daily for previously treated patients. Tablets should be taken with food. Your doctor may adjust the dose based on your response and side effects, with maximum doses of 600 mg daily.
Dosing of Bosutinib Newbury is individualized based on the specific indication, prior treatment history, and the patient's ability to tolerate the medication. Your oncologist will determine the right starting dose and make adjustments as needed throughout the course of treatment. It is essential to follow dosing instructions precisely and not to change the dose without medical guidance.
Adults
Newly Diagnosed Chronic-Phase CML (First-Line)
Starting dose: 400 mg taken orally once daily with food.
If the patient has not achieved a complete hematological response by week 8 or a complete cytogenetic response by week 12, and the current dose is well tolerated, the dose may be escalated to 500 mg once daily. The maximum recommended dose for dose escalation is 600 mg once daily.
Previously Treated CML (Second-Line or Later)
Starting dose: 500 mg taken orally once daily with food.
If the patient has not achieved a complete hematological response by week 8, and the current dose is well tolerated, the dose may be escalated to 600 mg once daily.
Children
Bosutinib Newbury is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of bosutinib in the pediatric population have not been established. Pediatric patients with CML should be managed according to guidelines for pediatric oncology under the care of a specialist center.
Elderly
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly hepatotoxicity, renal impairment, and cardiac events. Careful monitoring is advised, and dose adjustments may be needed based on individual tolerability and organ function.
Dose Adjustments for Organ Impairment
| Condition | Recommended Dose | Notes |
|---|---|---|
| Mild hepatic impairment (Child-Pugh A) | 200 mg once daily | May escalate to 300 mg if tolerated; close monitoring required |
| Moderate hepatic impairment (Child-Pugh B) | 200 mg once daily | Dose escalation not recommended |
| Severe hepatic impairment (Child-Pugh C) | Not recommended | Insufficient data; significant safety concerns |
| Mild renal impairment (CrCl 51–80 mL/min) | No adjustment needed | Monitor renal function regularly |
| Moderate renal impairment (CrCl 30–50 mL/min) | 300 mg once daily (first-line); 400 mg once daily (previously treated) | Close monitoring required; dose escalation with caution |
| Severe renal impairment (CrCl <30 mL/min) | 200 mg once daily | Limited data available; use with extreme caution |
Missed Dose
If you miss a dose, take it as soon as you remember on the same day. If more than 12 hours have passed since the scheduled time, skip the missed dose and take the next dose at the regular time the following day. Do not take a double dose to compensate for a missed one. If you vomit after taking a dose, do not take a replacement dose; wait and take the next dose at the normal scheduled time.
Overdose
There is limited experience with bosutinib overdose. If an overdose is suspected, the patient should be monitored and standard supportive measures should be implemented. There is no specific antidote for bosutinib. In the event of overdose, contact your local poison control center or emergency department immediately. Symptoms of overdose may include severe nausea, vomiting, diarrhea, and potentially dangerous changes in blood counts and liver function.
Contact your local poison control center or emergency department immediately. Bring the medication packaging with you to the hospital so that medical staff know exactly what has been taken.
What Are the Side Effects of Bosutinib Newbury?
The most common side effects of Bosutinib Newbury include diarrhea, nausea, vomiting, abdominal pain, rash, fatigue, and changes in blood counts. Diarrhea affects up to 80% of patients but usually improves within the first weeks. Serious side effects include hepatotoxicity, severe myelosuppression, fluid retention, and cardiac events.
Like all medicines, Bosutinib Newbury can cause side effects, although not everybody gets them. The side effect profile of bosutinib has been well characterized through extensive clinical trials involving thousands of patients. Understanding the possible side effects helps you recognize them early and seek appropriate medical attention when needed.
Most side effects are manageable with supportive care and dose adjustments. Your oncologist will monitor you closely, especially during the first months of treatment, and will make changes to your treatment plan as necessary to balance efficacy with tolerability.
Very Common
- Diarrhea – most frequent side effect, especially during the first 1–2 weeks
- Nausea – usually mild to moderate; tends to improve over time
- Vomiting – may occur, particularly in the early weeks
- Abdominal pain – including upper abdominal discomfort
- Rash – skin eruptions of various types
- Fatigue – tiredness, weakness, and lack of energy
- Thrombocytopenia – low platelet counts, increasing risk of bleeding
- Anemia – low red blood cell counts, causing tiredness and shortness of breath
- Neutropenia – low white blood cell counts, increasing risk of infections
- Elevated liver enzymes (ALT, AST) – indicating liver stress
- Headache – common, usually manageable with standard pain relief
- Decreased appetite – may contribute to weight loss
- Pyrexia (fever) – may be related to infection or the disease itself
Common
- Upper respiratory tract infection – colds, sore throat, sinusitis
- Pneumonia – lung infection requiring medical treatment
- Peripheral edema – swelling in the legs, ankles, or feet
- Pleural effusion – fluid around the lungs, causing breathlessness
- Cough – persistent cough, sometimes with shortness of breath
- Dizziness – lightheadedness or feeling unsteady
- Arthralgia and myalgia – joint and muscle pain
- Back pain – musculoskeletal discomfort
- Pruritus (itching) – skin itchiness with or without rash
- Increased lipase – elevated pancreatic enzyme level
- Renal impairment – decreased kidney function
- Elevated creatinine – marker of reduced kidney function
Uncommon
- Pericardial effusion – fluid around the heart
- QTc prolongation – change in heart electrical activity
- Pancreatitis – inflammation of the pancreas
- Hepatotoxicity – significant liver damage requiring dose change or discontinuation
- Pulmonary edema – fluid in the lungs
- Respiratory failure – severe breathing difficulty
- Erythema multiforme – serious skin reaction
- Drug-induced liver injury – significant hepatic damage
Rare
- Anaphylactic shock – severe allergic reaction (seek emergency care immediately)
- Stevens-Johnson syndrome – serious mucocutaneous reaction
- Tumor lysis syndrome – rapid release of cell contents into the blood
- Pulmonary hypertension – elevated blood pressure in the lung arteries
- Signs of severe liver problems: yellowing of the skin or eyes (jaundice), dark urine, severe abdominal pain
- Signs of severe infection: high fever, chills, persistent sore throat
- Signs of bleeding: unusual bruising, blood in urine or stool, prolonged bleeding from cuts
- Signs of fluid retention: sudden weight gain, severe swelling, difficulty breathing when lying flat
- Signs of heart problems: chest pain, irregular heartbeat, severe shortness of breath
- Severe or bloody diarrhea that does not respond to anti-diarrheal medication
It is important to report any new or worsening symptoms to your healthcare team promptly. Early detection and management of side effects can often prevent more serious complications and help you stay on treatment. Many side effects can be effectively managed with dose adjustments or supportive medications without the need to discontinue bosutinib.
How Should You Store Bosutinib Newbury?
Store Bosutinib Newbury below 30°C in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister. Do not dispose of medicines in wastewater or household waste.
Proper storage of Bosutinib Newbury is essential to ensure the medication remains effective and safe throughout its shelf life. Improper storage conditions can degrade the active ingredient, potentially reducing the drug's efficacy or altering its safety profile.
- Temperature: Store below 30°C (86°F). Do not freeze.
- Moisture protection: Keep the tablets in the original blister packaging until ready to take. Do not transfer to pill organizers for long periods, as this exposes the tablets to moisture and light.
- Light protection: Store in the original carton to protect from light.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister after "EXP." The expiry date refers to the last day of that month.
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment, as cytotoxic medications require special handling.
- Keep out of reach: Always store this medicine out of the sight and reach of children. This is a potent anticancer medication and accidental ingestion by a child could be extremely dangerous.
When traveling, keep the medication in its original packaging and carry it in your hand luggage. Avoid leaving it in hot cars or in direct sunlight. If traveling to hot climates, consider a temperature-controlled travel pouch. Always carry a letter from your doctor confirming the prescription, particularly for international travel.
What Does Bosutinib Newbury Contain?
Each Bosutinib Newbury film-coated tablet contains 100 mg of bosutinib (as bosutinib monohydrate) as the active substance, along with inactive excipients including microcrystalline cellulose, croscarmellose sodium, poloxamer 188, povidone, and magnesium stearate.
Understanding the composition of your medication is important, particularly if you have known allergies to any pharmaceutical ingredients. The excipients (inactive ingredients) play essential roles in the manufacturing process, stability, and bioavailability of the tablet, but do not have pharmacological activity themselves.
Active substance
Each film-coated tablet contains 100 mg of bosutinib (as bosutinib monohydrate). Bosutinib monohydrate is a white to off-white crystalline powder. The monohydrate form is used because it offers improved stability and consistent pharmaceutical properties compared to the anhydrous form.
Inactive ingredients (excipients)
The other ingredients in the tablet core and film-coating include:
- Tablet core: Microcrystalline cellulose, croscarmellose sodium, poloxamer 188, povidone (K-30), and magnesium stearate
- Film-coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG, talc, and iron oxide yellow (E172)
The film-coating serves multiple purposes: it protects the active ingredient from degradation by light and moisture, makes the tablet easier to swallow, and masks any unpleasant taste. The yellow color from iron oxide helps distinguish the tablet from other medications you may be taking.
Bosutinib Newbury tablets do not contain lactose, gluten, or sucrose. If you have any known allergies or intolerances to pharmaceutical excipients, review the full list of ingredients with your pharmacist before starting treatment.
Frequently Asked Questions About Bosutinib Newbury
Bosutinib Newbury is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adult patients. It may be used as a first-line treatment for newly diagnosed chronic-phase CML or for patients who have been previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options.
The most common side effects include diarrhea (affecting up to 80% of patients), nausea, vomiting, abdominal pain, rash, fatigue, fever, and changes in liver function tests. Diarrhea is typically most intense during the first few weeks of treatment and usually improves with supportive care and anti-diarrheal medications. Blood count abnormalities such as thrombocytopenia, anemia, and neutropenia are also common and require regular monitoring.
Yes, and in fact you should always take Bosutinib Newbury with food. Taking it with a meal significantly increases absorption and helps reduce gastrointestinal side effects such as nausea and diarrhea. Swallow the tablet whole with a glass of water – do not crush, break, or chew the tablet.
If you miss a dose, take it as soon as you remember on the same day, provided fewer than 12 hours have elapsed. If more than 12 hours have passed, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for the missed one. If you vomit after taking a dose, do not take an additional dose. Contact your healthcare team if you frequently miss doses.
Yes, Bosutinib Newbury can interact with many medications. Strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, and ritonavir) can increase bosutinib levels significantly, while strong CYP3A4 inducers (such as rifampicin, phenytoin, and St. John's Wort) can reduce its effectiveness. Proton pump inhibitors and antacids can reduce absorption. Always tell your doctor about all medications, supplements, and herbal products you are taking before starting and during treatment.
Bosutinib Newbury is typically taken as a long-term treatment for as long as it continues to control your CML and the side effects remain manageable. Some patients who achieve sustained deep molecular responses may be eligible to discuss treatment-free remission with their oncologist, but this should never be attempted without close medical supervision. Your specialist will determine the best course of action based on your individual treatment response and tolerance.
Regular monitoring includes complete blood counts (weekly for the first month, then monthly or as clinically indicated), liver function tests (monthly for the first 3 months, then as needed), kidney function tests, and BCR-ABL transcript levels (typically every 3 months) to evaluate treatment response. Your doctor will also monitor for signs of fluid retention, cardiac events, and other potential complications at regular clinic visits.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Bosutinib – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu
- Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018;36(3):231–237.
- Brummendorf TH, Cortes JE, de Souza CA, et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the 24-month follow-up of the BELA trial. Br J Haematol. 2015;168(1):69–81.
- Hochhaus A, Baccarani M, Silver RT, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966–984.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia. Version 1.2025.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List (2023). Geneva: World Health Organization.
- U.S. Food and Drug Administration (FDA). Bosulif (bosutinib) – Prescribing Information. Available at: www.fda.gov
- Khoury HJ, Cortes JE, Kantarjian HM, et al. Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood. 2012;119(15):3403–3412.
- European Society for Medical Oncology (ESMO). Chronic Myeloid Leukaemia: ESMO Clinical Practice Guidelines. Ann Oncol. 2017;28(suppl_4):iv41–iv51.
- Gambacorti-Passerini C, Cortes JE, Lipton JH, et al. Safety and efficacy of second-line bosutinib for chronic phase chronic myeloid leukemia over a five-year period: final results of a phase I/II study. Haematologica. 2018;103(8):1298–1307.
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Content prepared by specialist physicians with expertise in oncology and clinical pharmacology, following international guidelines from EMA, FDA, ESMO, and NCCN.
Independently reviewed by the iMedic Medical Review Board to ensure accuracy, completeness, and adherence to the GRADE evidence framework.
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