RhuFab V2
RhuFab V2 Uses, Dosage, Side Effects, Food Interaction and all others data.
RhuFab V2 is a recombinant humanised IgG1 kappa monoclonal antibody fragment which binds to active forms of human vascular endothelial growth factor A (VEGF-A) and inhibits their biologic activity. Binding of ranibizumab to VEGF-A inhibits VEGF from binding to its receptors, thereby suppressing neovascularisation (angiogenesis), endothelial cell proliferation and vascular permeability.
RhuFab V2 is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. RhuFab V2 is a VEGF-A antagonist that binds to and inhibits the biologic activity of active forms of human VEGF-A, including the cleaved form (VEGF110). VEGF-A has been shown to cause neovascularization (angiogenesis) and an increase in vascular permeability, which is thought to contribute to the progression of the neovascular form of age-related macular degeneration (AMD).
| Trade Name | RhuFab V2 |
| Generic | Ranibizumab |
| Ranibizumab Other Names | Ranibizumab, rhuFab V2 |
| Type | |
| Formula | C2158H3282N562O681S12 |
| Weight | 48349.611 Da |
| Protein binding | Plasma protein binding is insignificant. |
| Groups | Approved |
| Therapeutic Class | Drugs for Age-Related Macular Degeneration (AMD) |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
RhuFab V2 is used for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (Non Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR)) in patients with Diabetic Macular Edema (DME)
- Myopic Choroidal Neovascularization (mCNV)
RhuFab V2 is also used to associated treatment for these conditions: Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema, Subfoveal Choroidal Neovascularization, Wet Age-Related Macular Degeneration
How RhuFab V2 works
RhuFab V2 binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Dosage
RhuFab V2 dosage
Intravitreal (Adult)-
Neovascular (wet) age-related macular degeneration: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth.
Choroidal neovascularisation secondary to pathologic myopia: 0.5 mg into the affected eye as a single dose. Further injections may be given if monitoring reveals signs of disease activity (1-2 inj during the 1st yr; some patients may need more frequent treatment). Doses are given at intervals of at least 1 mth.
Diabetic macular oedema, Macular oedema secondary to retinal vein occlusion: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth. Discontinue treatment if no improvement in visual acuity after 3 initial inj.
Side Effects
Ocular pain, hyperaemia, irritation and pruritus; increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, headache, nasopharyngitis, arthralgia, thromboembolic events. Less frequently, endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract.
Toxicity
The most common toxic effects to the eye are eye pain, vitreous floaters, increased intraocular pressure, conjunctival hemorrhage, intraocular inflammation, and foreign body sensation. Also arterial thromboembolic events have occurred in patients.
Precaution
Patient with risk factors for retinal pigment epithelial tears, history of stroke or transient ischaemic attack, uncontrolled HTN, previous intravitreal inj, active systemic infections, proliferative diabetic retinopathy, diabetic macular oedema due to type 1 DM. Discontinue treatment if rhegmatogenous retinal detachment or stage 3 or 4 macular hole develops. Diabetic patients w/ glycosylated Hb over 12%.
Interaction
May enhance the adverse/toxic effect of belimumab. Serious intraocular inflammation may occur when used adjunctively with verteporfin photodynamic therapy (PDT).
Food Interaction
- Take with or without food.
Volume of Distribution
Volume of distribution is insignificant.
Elimination Route
After monthly intravitreal injections, maximum serum concentrations are minimal around 0.3 ng/mL to 2.36 ng/mL.
Half Life
Approximately 9 days.
Clearance
Clearance was not quantified.
Pregnancy & Breastfeeding use
Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
Active or suspected ocular or periocular infection, active severe intraocular inflammation, signs of irreversible ischaemic visual function loss in patients with retinal vein occlusion.
Acute Overdose
Symptoms: Increased intraocular pressure, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.
Management: Intraocular pressure should be monitored and treated by the attending physician, if necessary.
Storage Condition
Store between 2-8° C. Protect from light.
Innovators Monograph
You find simplified version here RhuFab V2
RhuFab V2 contains Ranibizumab see full prescribing information from innovator RhuFab V2 Monograph, RhuFab V2 MSDS, RhuFab V2 FDA label
FAQ
What is RhuFab V2 used for?
RhuFab V2 is used to treat wet age-related macular degeneration(an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities)
How safe is RhuFab V2?
RhuFab V2 has been well tolerated in clinical trials.
How does RhuFab V2 work?
RhuFab V2 works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss.
What are the common side effects of RhuFab V2?
Common side effects of RhuFab V2 are include:
- discomfort and increased tears in the affected eye(s),
- itchy or watery eyes,
- dry eyes,
- swelling of the eyelids,
- blurred vision,
- sinus pain,
- sore throat,
- cough
Is RhuFab V2 safe during pregnancy?
Women of childbearing potential should use effective contraception during treatment, and wait at least 3 months after the last dose before conceiving a child.
Is RhuFab V2 safe during breastfeeding?
Use with caution while breastfeeding; however, some experts recommend not breastfeeding during treatment as a precautionary measure.
How is this RhuFab V2 best taken?
Use bran as ordered by your doctor. Read all information given to you. Follow all instructions closely.Your doctor will give RhuFab V2.It is given as a shot into the eye.
How long does it take for RhuFab V2 to work?
RhuFab V2 can take as little as 7 days to have less fluid buildup in their retina and better vision.
How often is RhuFab V2 given?
RhuFab V2 is recommended to be administered by intravitreal injection once a month. Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment.
What happen if I overdose on RhuFab V2?
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Can RhuFab V2 cause blood clots?
RhuFab V2 may cause blood clots. This has caused serious medical emergencies, including heart attack or stroke.
Can I fly after RhuFab V2 injection?
RhuFab V2 is safe to fly 48 hours after your injection.
How good is RhuFab V2?
RhuFab V2 has an average rating of 7.5 out of 10 from a total of 6 ratings for the treatment of Macular Degeneration. 83% of reviewers reported a positive effect, while 17% reported a negative effect.
Who should not take RhuFab V2?
Before receiving RhuFab V2 tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
What happens if I miss a dose?
It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule.
