What is Dexagel?
Dexagel intravitreal implant is used to treat an eye disease called macular edema (swelling of the back of the eye). Macular edema occurs when a blood vessel in the eye is clogged. This causes vision changes that must be treated right away. Dexagel is a corticosteroid (steroid medicine) that helps reduce the swelling in the eye.
Dexagel intravitreal implant is also used to treat an eye disease called uveitis (swelling in the middle part of the eye). Dexagel is also used to treat diabetic macular edema in patients with artificial lens implant or are scheduled for cataract surgery.
Dexagel is to be given only by or under the supervision of your doctor.
Dexagel indications
Retinal Vein Occlusion
Dexagel® (Dexagel intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Posterior Segment Uveitis
Dexagel® is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
1.3 Diabetic Macular Edema
Dexagel® is indicated for the treatment of diabetic macular edema.
How should I use Dexagel?
Use Dexagel suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- If your doctor prescribed more than 1 eye medicine, find out the best order for using each medicine.
- Remove contact lenses before using Dexagel suspension.
- Shake well before each use.
- To use Dexagel suspension in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- If you miss a dose of Dexagel suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Dexagel suspension.
Uses of Dexagel in details
This medication is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. It is also used to test for an adrenal gland disorder (Cushing's syndrome). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. Dexagel is a corticosteroid hormone (glucocorticoid). This injectable form of Dexagel is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of Dexagel, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.
This drug may also be used with other medications as a replacement for certain hormones.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to prevent nausea and vomiting caused by cancer chemotherapy.
How to use Dexagel injection
This medication is given by injection into a vein, muscle, joint, or skin wound as directed by your doctor. Follow your doctor's directions carefully. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without consulting your doctor. Some patients (especially newborns) should receive the preservative-free form of this drug. In these patients, when mixing this form of the drug, be sure to use IV fluid that is also preservative-free. Use these mixtures within 24 hours.
If this medication is injected into a joint, be careful how much pressure you put on that joint, even if it is feeling better. Ask your doctor how much you can move/use the joint while it is healing.
If you have been using this medication for a long time, do not suddenly stop using it without your doctor's approval. Your dose may need to be gradually decreased to reduce symptoms such as weakness, weight loss, nausea, or extreme tiredness.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Tell your doctor if your condition persists or worsens.
Dexagel description
Dexagel is an intravitreal implant containing 0.7 mg (700 μg) Dexagel in the Dexagel solid polymer drug delivery system. Dexagel is preloaded into a single-use, specially designed DDS applicator to facilitate injection of the rod-shaped implant directly into the vitreous.
The Dexagel system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix. Dexagel is preservative-free. The chemical name for Dexagel is pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydoxy-16-methyl-,(11β, 16α). Its molecular weight is 392.47; molecular formula: C22H29FO3.
Dexagel occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.
The PLGA matrix slowly degrades to lactic acid and glycolic acid.
Dexagel dosage
Dexagel Dosage
Generic name: Dexagel 20mg
Dosage form: tablets
Medically reviewed by Drugs.com. Last updated on Oct 17, 2019.
2.1 Recommended Dosage
The recommended dosage of Dexagel is 20 mg or 40 mg, orally, once daily, on specific days depending on the treatment regimen. Refer to the Prescribing Information of the other anti-myeloma products used in combination with Dexagel for specific Dexagel dosing. Dexagel can be administered with or without food.
Dose Modification for Elderly Patients
Dose-reduction for Dexagel is recommended for elderly patients, due to increased toxicity in these patients. Refer to the Prescribing Information of the other anti-myeloma products used as part of a combination regimen with Dexagel, for dosing recommendations in elderly patients.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Related questions
- Can I use expired neomycin and polymyxin b sulfates, Dexagel ophthalmic?
Medical Disclaimer
More about Dexagel (Dexagel)
- Side Effects
- During Pregnancy or Breastfeeding
- Imprints, Shape & Color Data
- Drug Interactions
- Drug class: glucocorticoids
- FDA Alerts (7)
Consumer resources
Other brands: Dexagel, Dexagel Intensol, Dexasone, Baycadron,... +8 more
Professional resources
- Dexagel (FDA)
- ... +1 more
Related treatment guides
- Multiple Myeloma
Dexagel interactions
See also:
What other drugs will affect Dexagel?
Tablet/Forte Tablet: Barbiturates, Phenytoin, Ephedrine, Carbamazepine, Rifampicin and Other Drugs that Stimulate Hepatic Metabolism: May lessen the effect of Dexagel due to enhancement of Dexagel metabolism. Increase in Dexagel dosage may be required.
CYP3A4 Inhibitors eg, Ketoconazole and Macrolide Antibiotics: May increase plasma concentrations of corticosteroids.
Indinavir, Erythromycin and Other Drugs Metabolized by CYP3A4: Dexagel is a moderate inducer of CYP3A4 and may increase clearance of these drugs, resulting in decreased plasma concentrations.
Oral Contraceptives and Estrogen:
Can cause alterations in plasma protein-binding and metabolism of corticosteroids which can result in exposure of women to increased levels of the unbound corticosteroid for long periods of time.Aspirin: Concomitant use of aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) and corticosteroids increases the risk of gastrointestinal adverse effects. Use aspirin cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Concomitant administration of Dexagel and aspirin may also cause changes in salicylate plasma protein-binding and its rate of metabolism. These changes cause lowering of plasma salicylate levels.
Warfarin: Co-administration of corticosteroids and warfarin usually results in decreased response to warfarin, although there have been conflicting results.
Monitor coagulation indices frequently to maintain the desired anticoagulant effect.
Potassium-Depleting Agents eg, Diuretics and Amphotericin-B: Observe patients closely for the development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Anticholinesterase Agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, withdraw anticholinesterase agents at least 24 hrs before initiating corticosteroid therapy.
Antacids: Large doses of antacids cause alteration in corticosteroid absorption.
Insulin: Concomitant administration of Dexagel and insulin generally requires higher doses of insulin.
Ketoconazole: Decreases the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.
Thalidomide: Toxic epidermal necrolysis has been reported when Dexagel was used concomitantly with thalidomide.
Indomethacin: May cause false negative results in the Dexagel suppression test (DST).
Other Interactions: Toxoids and Live or Inactivated Vaccines: Patients on prolonged corticosteroid therapy may exhibit diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.
Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, postpone routine administration of vaccines or toxoids until corticosteroid therapy is discontinued.
Antidiabetic Agents: Dosage adjustment of antidiabetic agents may be required because corticosteroids may increase blood glucose concentrations.
Skin Tests: Corticosteroids may suppress reactions to skin tests.
Dexagel side effects
See also:
What are the possible side effects of Dexagel?
Clinical Studies Experience: Treatment of Macular Edema: Clinical Studies 206207‐008 and 206207‐009 (Initial 6‐month Treatment Period): The clinical safety of Dexagel was assessed in 2 phase 3 randomized, double‐masked, sham-controlled studies in patients with macular edema following BRVO or CRVO. In both studies, a total of 421 patients were randomized and received Dexagel and 423 received sham.
The most frequently reported adverse reactions considered to be related to the intravitreal injection procedure rather than the Dexagel implant, included vitreous hemorrhage and conjunctival edema.
Intraocular Pressure in the Initial 6‐month Treatment Period of Studies 008 and 009: See Table 4.
The proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was significantly greater with Dexagel compared to sham at days 7, 30, 60, and 90. At day 180, there were no significant differences between Dexagel and sham.
The proportion of patients experiencing increased IOP with Dexagel peaked at day 60 and returned to baseline levels by day 180. Elevations of IOP either did not require treatment or were managed with topical IOP‐lowering medications in the vast majority of patients. During the initial treatment period, only 0.7% (3/421) of the patients who received Dexagel required laser or surgical procedures for management of elevated IOP in the study eye compared with 0.2% (1/423) with sham.
Systemic effects with Dexagel would be expected to be negligible due to low systemic levels (below the lower level of quantitation). The adverse event profile for BRVO patients was generally similar to that observed for CRVO patients, and to the overall population. The overall incidence of adverse events was higher for the subgroup of patients with CRVO, which is consistent with the nature of the disease as patients with CRVO are more likely to develop ocular adverse events than patients with BRVO, even when not treated.
Clinical Studies 206207‐008 and 206207‐009 (6‐month Open‐label Extension): The clinical safety of Dexagel was further assessed in a 6‐month open‐label (OL) extension of both phase 3 studies. Patients were eligible for re‐treatment if the BCVA was <84 letters or retinal thickness was >250 mcg in the central 1 mm macular subfield and the investigator considered that the procedure would not put the patient at significant risk. The re‐treated population consisted of patients who received Dexagel, or sham as their 1st injection, completed the initial treatment period at day 180, and then received Dexagel as their 2nd injection. A total of 997 patients received the Dexagel injection in the open‐label phase of both studies.
For those events reported at a rate of ≥1%, the types of events and their incidence following the 2nd injection were similar to those seen following the 1st injection with the exception of subcapsular cataract which were higher in patients who had received Dexagel as their 1st injection followed by Dexagel as the 2nd injection. More specifically, subcapsular cataracts in the study eye were notably more common in the Dexagel/Dexagel group (12.9%) compared to either sham/Dexagel (3.4%).
For events reported in ≤1% of patients, mostly in only 1 or 2 patients per group, some differences between the 1st and 2nd injection were seen. Review of these differences does not suggest a safety signal associated with repeat treatments.
The incidence of IOP increased was comparable between patients receiving either 1 or 2 doses of Dexagel.
Treatment of Uveitis: Clinical Study 206207‐014: The clinical safety of Dexagel was assessed in a multicenter, masked, and randomized, 26‐week phase 3 study in the treatment of non‐infectious uveitis affecting the posterior segment of the eye. A total of 76 patients were treated with Dexagel and 75 were treated with sham.
Intraocular Pressure in Study ‐014: As shown in Table 7, there were no clinically meaningful differences in the proportions of Dexagel and sham patients who experienced IOP at ≥25 mmHg or ≥35 mmHg in the study eye, at any visit. At week 26, no Dexagel patients and 3 sham patients had an IOP ≥25 mmHg; no patients had an IOP ≥35 mmHg.
Table 8 shows the proportion of patients with increases from baseline IOP ≥10 mmHg in the study eye was similar between Dexagel and sham, except at week 8 where significantly higher percentages were observed with Dexagel (9.6%) compared to sham (0%), p=0.013. At week 26, only 1 Dexagel patient and 2 sham patients showed an increase from baseline IOP ≥10 mmHg.
The proportion of Dexagel‐treated patients with increased IOP (≥25 mmHg) peaked at week 3 and returned to baseline by week 26. During the treatment period, no patients required incisional surgery for glaucoma. Three patients required laser iridotomies in the study eye for the treatment of pupillary block, iris bombe, and raised IOP.
Post-Marketing Experience: The following adverse reactions have been identified during post-marketing use of Dexagel in clinical practice. Because post-marketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions. The reactions have been chosen for inclusion due to a combination of the frequency of reporting and/or possible causal connection to Dexagel.
Eye Disorders: Endophthalmitis: Hypotony of eye (associated with vitreous leakage due to injection), retinal detachment.
General Disorders and Administration Site Conditions: Complication of device insertion (implant misplacement), device dislocation with or without corneal edema.
Dexagel contraindications
See also:
What is the most important information I should know about Dexagel?
You should not use this medication if you are allergic to Dexagel, or if you have a fungal infection anywhere in your body.
Before taking Dexagel, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are taking Dexagel. Vaccines may not work as well while you are taking a steroid.
Do not stop using Dexagel suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Wear a medical alert tag or carry an ID card stating that you take Dexagel. Any medical care provider who treats you should know that you are using a steroid.
Active ingredient matches for Dexagel:
Dexamethasone in Bulgaria, Germany, Serbia, South Africa, Taiwan, Thailand.
Dexamethasone Na phosphate in Thailand.
Dexamethasone sodium phosphate in Germany.
| Unit description / dosage (Manufacturer) | Price, USD |
| Dexagel 0.1 % x 5 g | |
| Dexagel eye gel 0.1 % 5 g x 1's (Bausch & Lomb) | |
List of Dexagel substitutes (brand and generic names): | |
| DEXAGEE | |
| Dexagee NA Injection (Zydus Cadila) | $ 0.01 |
| Dexagel 0.1% (Egypt) | |
| Dexagil (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama) | |
| Dexagreen (Brazil) | |
| Dexagrin (Mexico) | |
| DexaHexal (Germany) | |
| Dexair | |
| Ointment; Ophthalmic; Dexamethasone Sodium Phosphate 0.05% | |
| Solution; Ophthalmic; Dexamethasone Sodium Phosphate 0.1% | |
| Dexaject SP | |
| DEXAJET | |
| DEXAJET INJECTION 1 vial / 2 ML injection each (Parenteral Drugs India Ltd) | $ 0.11 |
| Dexaken | |
| Dexaken 0.5 mg Tablet (Kentreck Labs Pvt Ltd.) | $ 0.00 |
| Dexal (Lithuania) | |
| Dexal 2 mg Tablet (Alsun Pharma) | $ 0.02 |
| Dexal 0.1% | |
| Dexalab (India) | |
| Dexalab 4mg x 1mL VIAL / 10ml (Laborate Pharmaceuticals India Ltd.) | $ 0.16 |
| Dexalab 4mg x 1mL VIAL / 2ml (Laborate Pharmaceuticals India Ltd.) | $ 0.11 |
| Dexalab 4mg x 1mL VIAL / 30ml (Laborate Pharmaceuticals India Ltd.) | $ 0.44 |
| 4 mg x 1 mL x 10ml (Laborate Pharmaceuticals India Ltd.) | $ 0.16 |
| 4 mg x 1 mL x 2ml (Laborate Pharmaceuticals India Ltd.) | $ 0.11 |
| 4 mg x 1 mL x 30ml (Laborate Pharmaceuticals India Ltd.) | $ 0.44 |
| Dexalab 120 mg Injection (Laborate Pharmaceuticals India Ltd.) | $ 0.01 |
| Dexalab 40 mg Injection (Laborate Pharmaceuticals India Ltd.) | $ 0.02 |
| Dexalab 8 mg Injection (Laborate Pharmaceuticals India Ltd.) | $ 0.05 |
| DEXALAB 4MG INJECTION 1 vial / 10 ML injection each (Laborate Pharmaceuticals India Ltd.) | $ 0.16 |
| DEXALAB 4MG INJECTION 1 vial / 20 ML injection each (Laborate Pharmaceuticals India Ltd.) | $ 0.16 |
| DEXALAB 4MG INJECTION 1 vial / 30 ML injection each (Laborate Pharmaceuticals India Ltd.) | $ 0.44 |
| Dexalaf (Argentina) | |
| Dexalar (Paraguay) | |
| Dexaleb O | |
| Dexaleb O E/E Drop (Leben Laboratories Pvt Ltd) | $ 0.15 |
| Dexaler (Peru) | |
| Dexalergin Injections | |
| Injectable; Injection; Dexamethasone Sodium Phosphate | |
| Dexalet | |
| Dexalet 8 mg Injection (Dynamic Laboratories Pvt. Ltd.) | $ 0.05 |
| Dexalide | |
| Dexalide 0.5 mg Tablet (Allied Chemicals & Pharmaceuticals Pvt.Ltd.) | $ 0.00 |
| Dexalife (Vietnam) | |
| Dexalife 5 mg/1 mL x 50 tube x 1 mL | |
| Dexalocal 0.1% (Cyprus) | |
| Dexalocal Scalp Application | |
| Solution; Topical; Dexamethasone 1% | |
| Dexalog-N (India) | |
| Dexalog-N Dexamethasone sodium phosphate0.1 % w/v, Neomycin sulphate0.5 % w/v. EYE-DPS / 5ml (Prem Pharma) | $ 0.10 |
| 5ml (Prem Pharma) | $ 0.10 |
| DEXALOG-N eye drops 5ml (Prem Pharma) | $ 0.10 |
| Dexalona | |
| Dexaltin (Hong Kong, Japan, Malaysia, Singapore, Taiwan, Thailand) | |
| Dexaltin 1 mg/1 g x 1 g x 50's (Nippon Kayaku) | |
| Dexaltin 1 mg/1 g x 5 g x 10's (Nippon Kayaku) | |
| Dexaltin 1 mg/1 g x 5 g (Nippon Kayaku) | |
See 2859 substitutes for Dexagel | |
References
- DailyMed. "DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "dexamethasone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "dexamethasone". http://www.drugbank.ca/drugs/DB01234 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Dexagel are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dexagel. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| > 60 | 1 | 50.0% | |
| 30-45 | 1 | 50.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
