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Introduction to Lucentis

Brief Overview of Lucentis (Ranibizumab)

Lucentis, known by its generic name Ranibizumab, is a significant medical advancement in the treatment of various eye conditions. It is primarily used for wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and macular edema following retinal vein occlusion (RVO). Since its introduction in 2006, Lucentis has been administered in over 12 million doses, highlighting its widespread acceptance and effectiveness.

Role in Treating Eye Conditions

Lucentis plays a crucial role in managing and treating several serious eye conditions that can lead to vision loss. In wet AMD, it helps in slowing down the progression of the disease and in some cases, improving vision. For diabetic patients suffering from DME and DR, Lucentis is instrumental in reducing macular edema and improving visual acuity. It is also effective in treating mCNV and RVO, conditions that can severely impact vision if left untreated.

What is Lucentis?

Detailed Description of Lucentis

Lucentis is an FDA-approved injectable medication designed to treat eye diseases that cause vision loss. It belongs to a class of drugs known as anti-VEGF (Vascular Endothelial Growth Factor) therapy. Lucentis works by inhibiting the growth of abnormal blood vessels in the eye and reducing vascular permeability, which can lead to fluid leaks that damage the retina and impair vision.

The Class of Drugs it Belongs To (Anti-VEGF Therapy)

As an anti-VEGF drug, Lucentis is part of a treatment category that targets the VEGF protein, which stimulates the growth of new blood vessels. By blocking this protein, Lucentis helps prevent the formation of abnormal blood vessels in the eye, a common cause of vision loss in conditions like wet AMD and diabetic eye diseases.

How it Works in the Body

Lucentis is administered directly into the eye through an intravitreal injection. Once injected, it binds to the VEGF protein, inhibiting its activity. This action reduces the growth of abnormal blood vessels and decreases fluid leakage in the retina, thereby helping to preserve and sometimes improve vision in patients with retinal disorders.

Key Information about Lucentis

Indications and Usage

Lucentis is indicated for the treatment of patients with wet AMD, DME, DR, mCNV, and RVO. It is specifically designed for individuals who have shown symptoms of vision loss due to these conditions. The treatment is tailored to each condition, with dosing and administration frequency varying based on the specific eye disease being treated.

Notable Benefits and Limitations

The primary benefit of Lucentis is its ability to preserve and potentially improve vision in patients with certain eye diseases. It has been a game-changer in the treatment of these conditions, offering hope to many who previously had limited options. However, Lucentis is not a cure for these diseases and requires ongoing treatment to maintain its benefits. Additionally, it is not suitable for all patients, including those with certain types of eye or systemic infections, or those who are allergic to its ingredients.

Age Restrictions, if Any

Lucentis is primarily used in adult populations, particularly in older adults who are more prone to conditions like wet AMD. The safety and effectiveness of Lucentis in pediatric patients have not been established.

How to Use Lucentis

Administration and Dosage

Lucentis (ranibizumab) is administered as an intravitreal injection, meaning it is injected directly into the eye. This procedure is typically performed by a healthcare professional in a clinical setting. The dosage and frequency of Lucentis injections depend on the specific eye condition being treated. For most conditions, injections are given approximately every 28 days. However, the treatment regimen may be adjusted based on the patient’s response and the progression of the eye disease.

Instructions for Missed Doses and Follow-up Appointments

It is important for patients to adhere to their treatment schedule and not miss doses of Lucentis. If a patient misses an appointment for a Lucentis injection, they should contact their healthcare provider to reschedule as soon as possible. Consistent treatment is crucial for the effectiveness of Lucentis. Regular follow-up appointments are also necessary to monitor the patient’s response to the treatment and to check for any side effects.

Storage Information

Proper Storage Conditions

Lucentis should be stored in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). It should not be frozen. The medication should be kept in the original container until it is time for it to be used. It is important to protect Lucentis from light and avoid shaking the vial or syringe.

Handling and Disposal

Handling of Lucentis should be done with care, and it should only be prepared for injection by a qualified healthcare professional. After use, any unused solution and the container should be disposed of in accordance with local regulations for biological waste. Patients should not attempt to dispose of the medication on their own but should follow the guidance of their healthcare provider or pharmacist.

Potential Risks and Benefits

Benefits of Lucentis

Lucentis has been proven to be effective in improving vision or preventing further vision loss in individuals with certain eye conditions, such as wet AMD, DME, DR, mCNV, and RVO. For many patients, Lucentis can significantly improve quality of life by preserving their sight. In some cases, patients may even experience an improvement in their vision after starting treatment with Lucentis.

Risks and Precautions

While Lucentis is beneficial for many patients, it does come with potential risks. The most common side effects include bleeding in the eye, eye pain, floaters, and increased eye pressure. More serious risks include endophthalmitis (inflammation inside the eye), detachment of the retina, and blood clots that can lead to heart attacks or strokes. Patients should be aware of these risks and discuss them with their healthcare provider. It is also important for patients to report any changes in their vision or eye pain to their healthcare provider immediately.

Contraindications

Lucentis is not recommended for patients who have an infection in or around the eye or who are allergic to ranibizumab or any of its ingredients. Patients with certain pre-existing eye conditions may also need to use Lucentis with caution.

Despite Lucentis being an effective treatment for certain eye conditions, it is important for patients to be aware of its potential side effects and risks. Regular monitoring and open communication with a healthcare provider are key to managing these risks effectively.

Side Effects of Lucentis

Common Side Effects

Lucentis (ranibizumab), while effective in treating certain eye conditions, can cause a range of side effects. Commonly reported mild side effects include ocular hemorrhage (bleeding in the eye), which may manifest as red spots in the eye, and eye pain or discomfort, often described as a sensation of pressure or soreness. Patients may also notice floaters, small moving spots in their vision, which can be distracting and affect visual clarity. Additionally, mild allergic reactions like skin rash, itchiness, and flushing can occur, typically presenting as localized redness or irritation on the skin. These side effects, while generally not severe, can cause discomfort and may impact daily activities. It is essential for patients to monitor these symptoms and report any persistent or bothersome side effects to their healthcare provider for appropriate management.

Serious Side Effects

Although less common, Lucentis can lead to serious side effects that necessitate immediate medical attention. One such side effect is increased intraocular pressure, which, if left untreated, can progress to glaucoma, a condition that may result in permanent vision loss. Endophthalmitis, a severe inflammation inside the eye often accompanied by pain, redness, and decreased vision, is another serious complication that can arise post-injection. Retinal detachment, characterized by a sudden increase in floaters, flashes of light, or a shadow or curtain effect over the field of vision, is a critical condition that can lead to significant vision loss if not promptly treated. Additionally, systemic side effects like blood clots leading to heart attacks or strokes have been reported, though these are rare. Patients experiencing any signs of these serious side effects should seek immediate medical care.

Allergic Reactions

Allergic reactions to Lucentis, while uncommon, can range from mild to severe. Mild reactions typically involve skin manifestations such as rashes, itching, or flushing, usually localized and manageable. However, in rare cases, patients may experience severe allergic reactions, which are medical emergencies. These severe reactions can include pronounced swelling under the skin, particularly noticeable in the eyelids, lips, hands, or feet, and significant swelling of the tongue, mouth, or throat, potentially leading to breathing difficulties. Such reactions require immediate medical intervention. Patients should be aware of these potential allergic responses and are advised to seek urgent medical attention if they experience symptoms indicative of a severe allergic reaction.

Understanding the side effects of Lucentis is crucial for patients undergoing treatment. While most side effects are mild and manageable, awareness of serious side effects and allergic reactions is essential for timely medical intervention. Regular consultations and open communication with healthcare providers are key to safely managing these risks and ensuring the best possible outcomes from Lucentis treatment.

Drug Interactions

Interactions with Other Medications Lucentis has not been shown to interact significantly with other medications, herbs, supplements, foods, or alcohol. However, it’s crucial for patients to inform their healthcare providers about all medications and supplements they are taking. This information helps healthcare providers to avoid potential interactions and ensure the safe and effective use of Lucentis.

Managing Drug Interactions Since Lucentis is administered by a healthcare professional and does not have known significant interactions with other substances, the management of drug interactions primarily involves patient disclosure of their current medications and supplements. Healthcare providers can then assess any potential risks and advise patients accordingly.

Warnings and Precautions for Lucentis

Precautions for Specific Populations

Patients considering Lucentis treatment should be aware of specific precautions, especially if they have certain pre-existing conditions. Those with an active infection in or around the eye are advised to delay treatment until the infection is resolved, as Lucentis injections could exacerbate the condition. Patients with a history of increased intraocular pressure or glaucoma should be closely monitored, as Lucentis can potentially elevate eye pressure. Additionally, individuals who have previously experienced allergic reactions to Lucentis or its components should discuss alternative treatments with their healthcare provider. The decision to proceed with Lucentis in these cases requires a thorough evaluation of the potential risks and benefits, balancing the need for treatment against the possibility of adverse reactions.

Pregnancy and Breastfeeding

The safety of Lucentis during pregnancy and breastfeeding remains unclear. Pregnant women should consider Lucentis only if the potential benefit justifies the potential risk to the fetus. Women planning to conceive should be informed about the potential risks. Similarly, it is not known whether Lucentis is excreted in human breast milk. Breastfeeding mothers should either discontinue breastfeeding or the drug, taking into account the importance of the drug to the mother. Women of childbearing potential should be advised to use effective contraception during treatment and for a period after the last dose.

Other Considerations

Before initiating Lucentis treatment, patients should provide a comprehensive health history to their healthcare provider. This includes any past eye infections, surgeries, or treatments, as well as a history of systemic conditions that might contraindicate intravitreal injections. Patients with a history of stroke or heart attack should also discuss these conditions, as there may be an increased risk of arterial thromboembolic events with Lucentis. The healthcare provider may consider alternative treatments or additional monitoring for patients with these risk factors.

Clinical Studies and Research on Lucentis

Overview of Clinical Trials Lucentis (ranibizumab) has been extensively studied in clinical trials for its effectiveness in treating various eye conditions. These trials have primarily focused on neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). The trials have demonstrated the efficacy of Lucentis in improving or stabilizing vision in these conditions.

Key Findings from Clinical Trials In one of the pivotal trials for wet AMD, Lucentis was compared with photodynamic therapy. Over two years, Lucentis preserved vision in 93% of patients and improved vision in 37%, compared to 65% and 9%, respectively, for photodynamic therapy. Another trial compared monthly injections of Lucentis to less frequent injections, finding that monthly treatment was more effective in maintaining vision. Similar positive outcomes were observed in trials for other eye conditions treated with Lucentis.

Long-Term Efficacy and Safety Data Long-term data from these trials indicate that Lucentis is not only effective in the short term but also helps maintain vision over extended periods. The safety profile of Lucentis has been well-established, with consistent monitoring of side effects and adverse reactions in patients.

Patient Information and Instructions

Understanding Lucentis Treatment Patients prescribed Lucentis should understand that it is a biologic medication used to treat specific eye conditions. It works by inhibiting VEGF, a factor that contributes to abnormal blood vessel growth and fluid leakage in the eye. Lucentis is administered as an injection directly into the eye by a healthcare professional.

Instructions for Treatment and Follow-up Patients should follow their treatment schedule strictly and attend all appointments for Lucentis injections. They should also be aware of the need for regular eye exams and monitoring to assess the effectiveness of the treatment and to check for any side effects. Patients should report any changes in vision or eye discomfort to their healthcare provider immediately.

Managing Side Effects and Concerns Patients should be informed about the potential side effects of Lucentis, including mild effects like eye pain or irritation and serious effects like increased eye pressure or retinal detachment. They should know the signs of serious side effects and when to seek immediate medical attention. Additionally, patients should discuss any concerns or questions they have about Lucentis treatment with their healthcare provider.

In summary, clinical studies have shown Lucentis to be an effective treatment for various serious eye conditions, with a well-established safety profile. Patients receiving Lucentis should be well-informed about their treatment, adhere to their injection schedule, and maintain regular communication with their healthcare provider to ensure the best possible outcomes.

Frequently Asked Questions

Lucentis is primarily used to treat several serious eye conditions, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). These conditions can lead to significant vision loss, and Lucentis works by inhibiting abnormal blood vessel growth and fluid leakage in the eye, helping to preserve and sometimes improve vision.

Lucentis is administered as an intravitreal injection, meaning it is injected directly into the eye. This procedure is typically performed by an ophthalmologist or a trained healthcare professional in a clinical setting. The frequency of injections depends on the specific condition being treated, with most patients receiving injections approximately every month.

Common side effects of Lucentis include bleeding in the eye, eye pain, floaters, increased eye pressure, and mild allergic reactions like skin rash, itchiness, and flushing. While these side effects are generally manageable, they can be bothersome and should be monitored. Patients should report any persistent or severe side effects to their healthcare provider.

Lucentis is not a cure for eye conditions like wet AMD or DME but is a treatment that can significantly slow the progression of the disease and, in some cases, improve vision. It’s a part of ongoing treatment plans and requires regular injections to maintain its benefits.

The safety of Lucentis during pregnancy is not well established. It is advised to avoid using Lucentis during pregnancy unless absolutely necessary. Women of childbearing potential should use effective contraception during treatment with Lucentis and for a specified period after the last dose.

In clinical trials for wet AMD, Lucentis has been shown to preserve vision in a significant percentage of patients and improve vision in some cases. It has been a major advancement in the treatment of this condition, offering hope to many who previously had limited options.

If you miss an appointment for a Lucentis injection, contact your healthcare provider to reschedule as soon as possible. Consistent treatment is crucial for the effectiveness of Lucentis, and missed doses can affect treatment outcomes.

Long-term side effects of Lucentis can include increased risk of eye infections, retinal detachment, and cataracts. Regular monitoring by an eye care professional is essential to detect and manage these potential long-term effects.

The safety and effectiveness of Lucentis in pediatric patients have not been established. Currently, Lucentis is approved only for use in adults.

Lucentis works by targeting and inhibiting Vascular Endothelial Growth Factor (VEGF), a protein that stimulates the growth of abnormal blood vessels in the eye. By blocking VEGF, Lucentis helps prevent the formation of these blood vessels and reduces fluid leakage, which can lead to vision loss.

Patients using Lucentis should be aware of the potential for eye infections and increased eye pressure. It’s important to report any changes in vision or eye discomfort to your healthcare provider immediately. Avoid activities that may expose the eye to contamination or pressure changes soon after an injection.

It’s generally recommended to avoid driving immediately after receiving a Lucentis injection as the procedure can temporarily affect vision. Patients should plan to have someone drive them home after the treatment and only resume driving once their vision has stabilized and they feel comfortable.

As of now, there is no generic version of Lucentis available. Lucentis is a biologic medication, and while biosimilars (similar to generics for biologic drugs) may become available, they are not identical to the original biologic and must be approved by regulatory authorities.

The duration of treatment with Lucentis varies depending on the individual’s response and the specific eye condition being treated. Some patients may require long-term treatment with regular injections to maintain vision and control their condition.

Risks associated with Lucentis injections include infection, increased eye pressure, retinal detachment, and hemorrhage in the eye. These risks are generally low but require immediate attention if they occur.

Lucentis can be used with other eye medications, but it’s important to inform your healthcare provider about all medications you are taking. This will help avoid potential interactions and ensure the safe and effective use of Lucentis.

The cost of Lucentis treatment can be high, and it varies based on insurance coverage, geographic location, and dosage requirements. Patients should consult with their insurance provider and healthcare provider to understand the cost and explore any available financial assistance programs.

Lucentis is specifically designed for intraocular use and has a molecular structure optimized for eye conditions. While other anti-VEGF treatments like Avastin and Eylea are also used for similar conditions, Lucentis has unique dosing and efficacy profiles tailored for ocular diseases.

Allergic reactions to Lucentis are rare but can occur. Symptoms can range from mild (such as skin rash and itchiness) to severe (such as swelling and difficulty breathing). Patients should seek immediate medical attention if they experience signs of a severe allergic reaction.

Before starting Lucentis, discuss your complete medical history, including any previous eye conditions and surgeries, with your healthcare provider. It’s also important to mention any allergies, current medications, and overall health status to assess the suitability of Lucentis for your condition.