Dalalone 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. Dalalone is a corticosteroid (steroid medicine) that helps reduce the swelling in the eye.
Dalalone intravitreal implant is also used to treat an eye disease called uveitis (swelling in the middle part of the eye). Dalalone is also used to treat diabetic macular edema in patients with artificial lens implant or are scheduled for cataract surgery.
Dalalone is to be given only by or under the supervision of your doctor.
Dalalone indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Retinal Vein Occlusion
Dalalone® (Dalalone 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
Dalalone® is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
1.3 Diabetic Macular Edema
Dalalone® is indicated for the treatment of diabetic macular edema.
How should I use Dalalone?
Use Dalalone 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 Dalalone suspension.
Shake well before each use.
To use Dalalone 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 Dalalone 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 Dalalone suspension.
Uses of Dalalone in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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. Dalalone is a corticosteroid hormone (glucocorticoid). This injectable form of Dalalone 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 Dalalone, 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 Dalalone 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.
Dalalone description
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Dalalone is an intravitreal implant containing 0.7 mg (700 μg) Dalalone in the Dalalone solid polymer drug delivery system. Dalalone is preloaded into a single-use, specially designed DDS applicator to facilitate injection of the rod-shaped implant directly into the vitreous.
The Dalalone system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix. Dalalone is preservative-free. The chemical name for Dalalone 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.
Dalalone 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.
Dalalone dosage
Dalalone Dosage
Generic name: Dalalone 20mg
Dosage form: tablets
Medically reviewed by Drugs.com. Last updated on Oct 17, 2019.
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2.1 Recommended Dosage
The recommended dosage of Dalalone 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 Dalalone for specific Dalalone dosing. Dalalone can be administered with or without food.
Dose Modification for Elderly Patients
Dose-reduction for Dalalone 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 Dalalone, 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
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Tablet/Forte Tablet:Barbiturates, Phenytoin, Ephedrine, Carbamazepine, Rifampicin and Other Drugs that Stimulate Hepatic Metabolism: May lessen the effect of Dalalone due to enhancement of Dalalone metabolism. Increase in Dalalone 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: Dalalone 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 Dalalone 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 Dalalone 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 Dalalone was used concomitantly with thalidomide.
Indomethacin: May cause false negative results in the Dalalone 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.
Clinical Studies Experience:Treatment of Macular Edema: Clinical Studies 206207‐008 and 206207‐009 (Initial 6‐month Treatment Period): The clinical safety of Dalalone 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 Dalalone and 423 received sham.
The most frequently reported adverse reactions considered to be related to the intravitreal injection procedure rather than the Dalalone 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 Dalalone compared to sham at days 7, 30, 60, and 90. At day 180, there were no significant differences between Dalalone and sham.
The proportion of patients experiencing increased IOP with Dalalone 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 Dalalone 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 Dalalone 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 Dalalone 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 Dalalone, or sham as their 1st injection, completed the initial treatment period at day 180, and then received Dalalone as their 2nd injection. A total of 997 patients received the Dalalone 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 Dalalone as their 1st injection followed by Dalalone as the 2nd injection. More specifically, subcapsular cataracts in the study eye were notably more common in the Dalalone/Dalalone group (12.9%) compared to either sham/Dalalone (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 Dalalone.
Treatment of Uveitis: Clinical Study 206207‐014: The clinical safety of Dalalone 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 Dalalone 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 Dalalone and sham patients who experienced IOP at ≥25 mmHg or ≥35 mmHg in the study eye, at any visit. At week 26, no Dalalone 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 Dalalone and sham, except at week 8 where significantly higher percentages were observed with Dalalone (9.6%) compared to sham (0%), p=0.013. At week 26, only 1 Dalalone patient and 2 sham patients showed an increase from baseline IOP ≥10 mmHg.
The proportion of Dalalone‐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 Dalalone 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 Dalalone.
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.
You should not use this medication if you are allergic to Dalalone, or if you have a fungal infection anywhere in your body.
Before taking Dalalone, 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 Dalalone. Vaccines may not work as well while you are taking a steroid.
Do not stop using Dalalone 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 Dalalone. Any medical care provider who treats you should know that you are using a steroid.
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).
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