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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Cimerli
Generic Name
Ranibizumab-eqrn
Active Ingredient
RanibizumabCategory
Vascular Endothelial Growth Factor Inhibitor [EPC]
Variants
4
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Cimerli, you must consult a qualified healthcare professional.
| .5 mg/.05mL | INJECTION, SOLUTION | INTRAVITREAL | 61314-625 |
Detailed information about Cimerli
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor used to treat various retinal conditions, including wet age-related macular degeneration and diabetic retinopathy, by preventing abnormal blood vessel growth and leakage in the eye.
The dosage of ranibizumab is highly specific to the condition being treated and is administered exclusively by a trained ophthalmologist (eye specialist).
Ranibizumab is not generally used in the standard pediatric population, with one major exception: Retinopathy of Prematurity (ROP). For ROP, the dose is significantly lower than the adult dose (typically 0.2 mg). However, this use is highly specialized and must be managed by a pediatric ophthalmologist. For all other conditions, safety and effectiveness in pediatric patients have not been established.
Formal studies have not been conducted in patients with renal impairment. However, since systemic exposure to ranibizumab is extremely low following intravitreal injection, dose adjustments are generally not required for patients with kidney disease.
No formal studies have been conducted in patients with hepatic (liver) impairment. Similar to renal impairment, the low systemic concentration of the drug suggests that dose adjustments are unnecessary for these patients.
A significant proportion of patients in clinical trials for AMD were over the age of 65. No overall differences in safety or efficacy were observed between older and younger patients, and no age-related dose adjustments are recommended.
Ranibizumab is administered as an injection into the vitreous (the jelly-like substance inside the eye). The procedure involves several steps:
Patients should avoid rubbing their eyes after the injection and should follow all instructions regarding the use of post-operative eye drops if prescribed.
If a scheduled injection is missed, it should be rescheduled as soon as possible. Delaying treatment can lead to a recurrence of fluid leakage and potential permanent vision loss. Your ophthalmologist will determine the best timing for the next dose to maintain the treatment effect.
An overdose in the context of ranibizumab usually refers to an accidental administration of a higher-than-intended volume or dose into the eye. This can lead to a dangerous increase in intraocular pressure (IOP). Symptoms of increased IOP include severe eye pain, headache, and sudden blurred vision. In the event of an overdose, the ophthalmologist will monitor the intraocular pressure closely and may perform a procedure to relieve the pressure if necessary.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or skip appointments without medical guidance, as this may result in irreversible vision loss.
Because ranibizumab is injected directly into the eye, most side effects are localized to the injection site. Common side effects include:
Ranibizumab is a potent medication that must be administered under strict aseptic (sterile) conditions. The most critical safety concern is the risk of endophthalmitis (a severe internal eye infection). Patients must be educated to recognize the early signs of infection and seek care immediately. Furthermore, because ranibizumab can cause temporary vision blurring or light sensitivity, patients should not drive or operate heavy machinery until their vision has recovered from the injection procedure.
No FDA black box warnings for Ranibizumab. While it is a high-risk procedure, the safety profile does not currently meet the FDA criteria for a boxed warning.
There are no known systemic drugs that are strictly contraindicated with ranibizumab due to its localized administration and low systemic absorption. However, it should not be used in combination with other intravitreal VEGF inhibitors (e.g., aflibercept, faricimab) in the same eye at the same time, as there is no evidence that 'double-blocking' VEGF provides additional benefit, and it may increase the risk of side effects.
Ranibizumab must NEVER be used in the following circumstances:
Ranibizumab is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. However, VEGF is known to play a critical role in angiogenesis and the development of the fetal vascular system. Theoretically, systemic exposure to a VEGF inhibitor could interfere with normal fetal development or lead to pregnancy loss. Animal studies using high systemic doses have shown reproductive toxicity. Ranibizumab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Women of childbearing potential should discuss effective contraception with their doctor while receiving treatment.
It is not known whether ranibizumab is excreted in human milk. Because many drugs and proteins are excreted in milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Most experts suggest a cautious approach, often waiting a certain period after injection before breastfeeding, though data is limited.
Ranibizumab is a high-affinity antibody fragment (Fab) that binds to and neutralizes all biologically active isoforms of Vascular Endothelial Growth Factor A (VEGF-A). VEGF-A is a glycoprotein that induces angiogenesis, vascular leakage, and inflammation. By binding to the receptor-binding site of VEGF-A, ranibizumab prevents the protein from binding to its receptors, VEGFR1 and VEGFR2, on the surface of vascular endothelial cells. This action stops the signaling cascade that leads to the proliferation of abnormal blood vessels and the breakdown of the blood-retinal barrier.
The primary pharmacodynamic effect of ranibizumab is the reduction of macular edema and the inhibition of neovascularization. Following injection, a decrease in central retinal thickness can often be seen on OCT imaging within 24 to 48 hours. The duration of effect typically lasts 4 to 6 weeks, which is why monthly dosing is the standard initial approach. Unlike full antibodies, the Fab fragment lacks an 'Fc' region, which may reduce the risk of systemic immune-mediated clearance and inflammatory responses.
Common questions about Cimerli
Ranibizumab is primarily used to treat several serious eye conditions that cause vision loss, including 'wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is also approved for treating swelling in the retina caused by retinal vein occlusion (RVO) and for diabetic retinopathy. By blocking a protein called VEGF, it prevents the growth of abnormal, leaky blood vessels in the back of the eye. This helps to reduce retinal swelling and can prevent further vision loss or even improve sight in many patients. Your ophthalmologist will determine if this treatment is appropriate based on specialized imaging of your retina.
The most common side effects are usually related to the injection process itself rather than the medication. These include conjunctival hemorrhage (a red spot on the white of the eye), eye pain, and the appearance of 'floaters' or small specks in your vision. Some patients may also experience a temporary increase in eye pressure immediately after the injection. Most of these symptoms are mild and resolve within a few days. However, any persistent or worsening pain should be reported to your doctor immediately to rule out more serious complications.
There are no known direct drug interactions between ranibizumab and alcohol. Because the medication is injected into the eye and very little reaches the rest of your body, alcohol does not interfere with how the drug works. However, it is always wise to consume alcohol in moderation, as it can affect your overall vascular health and hydration, which are important for eye health. If you are prone to dizziness or balance issues after an injection, alcohol may worsen these effects. Always follow the specific lifestyle advice provided by your eye specialist.
Ranibizumab is generally not recommended during pregnancy unless the potential benefits significantly outweigh the risks to the fetus. It is classified as Category C, meaning animal studies have shown potential harm but there is insufficient data in humans. VEGF is a protein essential for the development of a baby's blood vessels, so blocking it could theoretically cause developmental issues. Women who are pregnant or planning to become pregnant should have a detailed discussion with their ophthalmologist and obstetrician. Effective contraception is usually recommended during treatment and for several months after the last dose.
Many patients begin to show signs of improvement, such as a reduction in retinal swelling, within just a few days of the first injection. However, the full effect on visual acuity may take several months of consistent, monthly treatments to become apparent. In clinical trials, the most significant gains in vision were typically measured after three to six months of regular dosing. It is important to remember that for some patients, the goal of treatment is to stabilize vision and prevent further loss rather than to achieve a dramatic improvement. Your doctor will use OCT scans to monitor your progress.
Stopping ranibizumab injections abruptly can be very dangerous for your vision. If the underlying condition (like wet AMD) is still active, stopping treatment can cause a rapid 'rebound' of fluid and blood leakage in the retina. This can lead to a sudden and permanent drop in your ability to see. If you need to stop treatment, your doctor will usually monitor you very closely or try to extend the time between injections gradually. Never skip an appointment without consulting your ophthalmologist first, as consistency is key to saving your sight.
If you miss an appointment for your ranibizumab injection, you should contact your eye clinic immediately to reschedule. Timing is critical in anti-VEGF therapy to keep the abnormal blood vessels from leaking again. A delay of even a few weeks can sometimes allow fluid to build up, which may damage the delicate cells of the retina. Your doctor will help you get back on track with your treatment schedule as quickly as possible. Most clinics recommend setting reminders for these appointments because of their importance in maintaining your vision.
There is no evidence from clinical trials or post-marketing surveillance to suggest that ranibizumab causes weight gain. The medication is administered locally into the eye, and the amount that enters the systemic circulation is extremely small. Systemic side effects like weight changes, which are common with oral steroids or other systemic medications, are not associated with this type of localized eye treatment. If you experience unexpected weight gain while on this medication, it is likely due to other factors or health conditions. You should discuss any significant changes in your weight with your primary care physician.
Ranibizumab is generally safe to use alongside most other systemic medications, such as those for high blood pressure or cholesterol. Because it is injected into the eye, it does not typically interact with drugs processed by the liver or kidneys. However, you should inform your ophthalmologist if you are using other eye drops, especially steroids, as they can also increase eye pressure. It is also important to mention if you are receiving systemic anti-VEGF treatments for cancer. Your doctor will coordinate your care to ensure all medications are working together safely.
Ranibizumab is not available as a 'generic' in the traditional sense, but several 'biosimilars' have been approved by the FDA. Biosimilars, such as Byooviz (ranibizumab-nuna) and Cimerli (ranibizumab-eqrn), are highly similar to the original brand (Lucentis) and have been proven to have no clinically meaningful differences in safety or effectiveness. These biosimilars are often more affordable options for patients and insurance providers. Your doctor will determine which version of ranibizumab is most appropriate for you based on clinical needs and insurance coverage. Both the original biologic and its biosimilars are administered in the same way.
Other drugs with the same active ingredient (Ranibizumab)
> Warning: Stop taking Ranibizumab and call your doctor immediately or seek emergency care if you experience any of these symptoms after an injection.
Prolonged use of ranibizumab (over several years) is generally well-tolerated. However, long-term suppression of VEGF has raised concerns about potential 'geographic atrophy' (thinning of the retina) in some patients with AMD, although it is unclear if this is caused by the drug or the natural progression of the underlying disease. Continuous monitoring of retinal thickness and health is required for the duration of therapy.
No FDA black box warnings for Ranibizumab. However, the FDA-approved labeling contains significant 'Warnings and Precautions' regarding endophthalmitis, retinal detachments, and the risk of thromboembolic events.
Report any unusual symptoms to your healthcare provider immediately. Early intervention for serious side effects is critical for preserving vision.
Patients receiving ranibizumab require intensive monitoring, including:
Following an injection, the eye is often dilated and may be covered with a patch or contain an antibiotic ointment. Vision will be blurred, and the eye may be sensitive to light. Patients should arrange for transportation home and avoid driving or operating machinery until the blurring and dilation have completely resolved, typically the following day.
There are no known direct interactions between alcohol and ranibizumab. However, alcohol can cause dehydration and may affect overall vascular health. Patients should follow their doctor's general health recommendations.
Stopping ranibizumab treatment abruptly can lead to a 'rebound' effect where fluid accumulates rapidly, leading to a significant and sometimes permanent loss of vision. Discontinuation should only be done under the guidance of an ophthalmologist, often through a gradual 'taper' or extension of the time between injections.
> Important: Discuss all your medical conditions, especially a history of glaucoma or stroke, with your healthcare provider before starting Ranibizumab.
There are no known interactions between ranibizumab and specific foods, including grapefruit, dairy, or high-fat meals. Because the drug bypasses the digestive system, food does not affect its absorption or efficacy.
Ranibizumab is not known to interfere with common blood or urine laboratory tests. It does not affect liver enzymes, creatinine, or blood counts in a clinically significant way.
Since ranibizumab is a protein fragment administered locally, it does not involve the standard drug-metabolism pathways (CYP450 enzymes). Interactions are primarily pharmacodynamic (how the drug affects the body) rather than pharmacokinetic (how the body handles the drug). For example, combining it with other drugs that raise eye pressure creates a cumulative effect on the eye's internal pressure.
The primary strategy for managing interactions with ranibizumab is clinical monitoring. Ophthalmologists will adjust the frequency of injections or the use of adjunctive therapies (like pressure-lowering drops) based on the patient's response and the presence of other medications.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially any other treatments for your eyes or systemic cancer therapies.
There is a potential for cross-sensitivity between ranibizumab and other VEGF inhibitors (like bevacizumab or aflibercept) because they share similar protein structures. If a patient has had a severe immune-mediated reaction to one anti-VEGF agent, the doctor will exercise extreme caution when switching to ranibizumab.
> Important: Your healthcare provider will evaluate your complete medical history, including any current infections or allergies, before prescribing Ranibizumab.
In clinical trials, approximately 75% of patients with AMD were 75 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. The pharmacokinetic profile does not change significantly with age, and no dose adjustments are required for the elderly.
Patients with renal impairment generally do not require dose adjustments. Although the drug is cleared renally from the systemic circulation, the amount of drug reaching the blood from the eye is so small that even significant kidney dysfunction is unlikely to lead to toxic systemic levels.
There is no evidence to suggest that liver disease affects the safety or efficacy of ranibizumab. Since the drug is broken down by proteases rather than the liver's CYP450 system, hepatic impairment does not necessitate dose changes.
> Important: Special populations, particularly pregnant women and infants, require individualized medical assessment and a thorough discussion of risks versus benefits.
| Parameter | Value |
|---|---|
| Bioavailability | N/A (Intravitreal) |
| Protein Binding | Negligible (Systemic) |
| Vitreous Half-life | ~9 days |
| Systemic Half-life | ~2 hours |
| Tmax (Plasma) | ~1 day |
| Metabolism | Proteolysis (Non-CYP) |
| Excretion | Renal (Minor) |
Ranibizumab is classified as an Antineovascular Agent and a VEGF Inhibitor. It is part of a therapeutic class that includes other biologics such as aflibercept (Eylea), bevacizumab (Avastin), and faricimab (Vabysmo). Within this class, ranibizumab is unique as a monoclonal antibody fragment specifically optimized for retinal penetration.