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Reporting side effects

Report a suspected side effect (also known as an adverse event) related to a Novartis Pharmaceutical drug or a Novartis Vaccine.

Reporting side effects

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Lucentis & Avastin

We’d like to share with you some perspectives on Novartis/Genentech’s Lucentis® (ranibizumab), a medication designed and developed specifically for use in ocular disease, and the key differences between Lucentis and Genentech/Roche’s Avastin® (bevacizumab), a medication licensed for applications in oncology. View the FAQ or download the PDFs to learn more.



What is Lucentis® (ranibizumab)?

What is Lucentis® (ranibizumab)?

  • Lucentis is a humanized therapeutic antibody fragment, with a short systemic half-life, designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A).
  • Lucentis was specifically designed, developed and manufactured for intravitreal ocular use, meaning for use in the eye.
  • Lucentis is the only anti-VEGF licensed for five ocular indications: wet age related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch-RVO and central-RVO and and for visual impairment due to choroidal neovascularization secondary to pathologic myopia. 1
  • Lucentis has a well characterized safety profile with more than 2.2 million patient-treatment years of exposure globally.
  • The Lucentis safety profile is continuously monitored for all of its licensed indications via a systematic pharmacovigilance system.

Who markets Lucentis?

Who markets Lucentis?

  • Lucentis was developed by Genentech and Novartis.
  • Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world.

Who markets Avastin® (bevacizumab)?

Who markets Avastin® (bevacizumab)?

  • Genentech/Roche formulated, developed and manufactures bevacizumab for the intravenous treatment of certain cancers.
  • Novartis does not have commercial rights to bevacizumab anywhere in the world.

Is there a difference between Lucentis and bevacizumab?

Is there a difference between Lucentis and bevacizumab?

  • Lucentis and bevacizumab are entirely different molecules with different chemical structures, and different biochemical, pharmacodynamic, pharmacokinetic and clinical profiles.
  • Lucentis was designed and developed specifically to treat wet age-related macular degeneration.
  • Bevacizumab was designed and is approved for the treatment of patients with certain forms of cancer and is not manufactured or approved by health authorities for use in the eye.

How does the manufacturing of Lucentis and bevacizumab compare?

How does the manufacturing of Lucentis and bevacizumab compare?

  • Lucentis is manufactured to the highest standards for use in the eye (intraocular or intravitreal use). Each therapeutic dose is is provided in single-use, preservative-free vials, ensuring stability and sterility of the product. It is administered according to its license.
  • Lucentis complies with US Pharmacopeia (USP 789) specific requirements for ophthalmic solutions, which are stricter than the requirements for parenteral (i.e. intravenous) products, such as bevacizumab.
  • Bevacizumab vials, which are intended for intravenous administration for certain cancers, meet the USP 788 manufacturing standards for intravenous formulations of drugs.
  • Lower levels of particulate matter must be achieved in medicines for use in the eye, than is necessary for agents for intravenous administration; bevacizumab does not meet the manufacturing standards for intraocular use.

Click here for more information on US Pharmacopeia USP 789 and USP 788

Are there safety differences between Lucentis and bevacizumab?

Are there safety differences between Lucentis and bevacizumab?

  • Before any medicine is determined appropriate to be licensed for use by the public, it is assessed by a regulatory body that performs a risk/benefit assessment based on the drug’s safety, efficacy and quality profile. This assessment has not been conducted for bevacizumab for use in the eye (intravitreal use). Bevacizumab is not licensed for intravitreal use.
  • While ophthalmologists are asked to report adverse events following intravitreal administration of bevacizumab to the pharmacovigilance system the use of unlicensed intravitreal bevacizumab is not supported by specific educational materials that provide information on the safe use and understanding of the product, and direct health care providers and patients to report adverse events.
  • There is a growing body of evidence suggesting safety concerns associated with the use of unlicensed use of bevacizumab in the eye. There are retrospective database analyses pointing to systemic and ocular safety issues with unlicensed intravitreal bevacizumab compared to Lucentis, as well as clinical studies and reports of clusters of ocular safety events with unlicensed intravitreal bevacizumab.

What is a licensed medication?

What is a licensed medication?

  • A marketing authorisation or product license defines a medicine’s terms of use: its product information includes among other things, the indication(s), recommended dose(s), contraindications, and special warnings and precautions for use on which the license is based, and it is in line with such use that the benefits of the medicine have been judged to outweigh the potential risks.
  • Furthermore, a licensed medicine has been assessed for efficacy, safety, and quality, and has been manufactured to appropriate quality standards.
  • When placed on the market a licensed medication is accompanied by appropriate product information and labeling, and ongoing pharmacovigilance safety monitoring relating to the usage of the product.

What does off-label prescribing mean?

What does off-label prescribing mean?

  • Off-label prescribing or use is the practice of a healthcare professional who, under his or her responsibility, prescribes pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration.
  • Doctors should inform patients and seek informed consent to the potential risks and benefits, if they are prescribing off-label.
  • The European Court of Justice has confirmed that cost or economic grounds are not valid reasons to justify prescribing an off-label drug.

What does unlicensed medication mean?

What does unlicensed medication mean?

  • Doctors may sometimes prescribe unlicensed medicines. A medicine that’s unlicensed either doesn’t have a marketing authorization, or doesn’t have a marketing authorization for the indication for which it is prescribed. For example:
    • A patient may have agreed to receive an unlicensed medicine as part of a clinical trial.
    • In Europe, compassionate-use programs exist for patients who have a disease with no satisfactory authorized therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development.
    • A patient may have a special clinical need that cannot be met by a licensed medicine, for example, they are allergic to an ingredient or cannot swallow tablets.
  • Doctors should inform patients and seek informed consent to the potential risks and benefits, if they are prescribing an unlicensed medication.

Can patients afford Lucentis? Isn’t it expensive?

Can patients afford Lucentis? Isn’t it expensive?

  • Novartis has an excellent track record of working with health authorities and reimbursement agencies across the world to secure statutory access to medicines for patients.
  • We take great care to price medicines fairly based on the value they deliver to patients, the scientific innovation they represent, the cost of the current therapies and the associated costs of research and development.
  • Authorities across the world using mandatory cost/benefit assessments have priced Lucentis according to their view of its value proposition to patients and society.



  • Fiction
  • Fact

There is no difference between Lucentis and bevacizumab.

Lucentis and bevacizumab are entirely different molecules with different chemical structures, and different biochemical, pharmacodynamic, pharmacokinetic and clinical profiles.
Lucentis was designed and developed specifically to treat wet age-related macular degeneration.
Bevacizumab was designed and is approved for the treatment of patients with certain forms of cancer and is not manufactured or approved by health authorities for use in the eye.

The same manufacturing standards apply to Lucentis and bevacizumab.

Lucentis is manufactured to the highest standards for use in the eye (intraocular or intravitreal use). Each therapeutic dose is is provided in single-use, preservative-free vials, ensuring stability and sterility of the product. It is administered according to its license.
Lucentis complies with US Pharmacopeia (USP 789) specific requirements for ophthalmic solutions, which are stricter than the requirements for parenteral (i.e. intravenous) products, such as bevacizumab.
Bevacizumab vials, which are intended for intravenous administration for certain cancers, meet the USP 788 manufacturing standards for intravenous formulations of drugs.
Lower levels of particulate matter must be achieved in medicines for use in the eye, than is necessary for agents for intravenous administration; bevacizumab does not meet the manufacturing standards for intraocular use.
Click here for more information on US Pharmacopeia USP 789 and USP 788.

There are no safety differences between Lucentis and bevacizumab.

Before any medicine is determined appropriate to be licensed for use by the public, it is assessed by a regulatory body that performs a risk/benefit assessment based on the drug’s safety, efficacy and quality profile. This assessment has not been conducted for bevacizumab for use in the eye (intravitreal use). Bevacizumab is not licensed for intravitreal use.
While ophthalmologists are asked to report adverse events following intravitreal administration of bevacizumab to the pharmacovigilance system the use of unlicensed intravitreal bevacizumab is not supported by specific educational materials that provide information on the safe use and understanding of the product, and direct health care providers and patients to report adverse events.
There is a growing body of evidence suggesting safety concerns associated with the use of unlicensed use of bevacizumab in the eye. There are retrospective database analyses pointing to systemic and ocular safety issues with unlicensed intravitreal bevacizumab compared to Lucentis, as well as clinical studies and reports of clusters of ocular safety events with unlicensed intravitreal bevacizumab.

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Avastin® is a registered trademark of Genentech/Roche.

  1. Lucentis (ranibizumab). Summary of Product Characteristics. Novartis Pharma AG. 10 January 2012. Available at http://www.ema.europa.eu.