Dalalone DP Side effects

• Side effects of Dalalone DP in details
• Dalalone DP contraindications
• Dalalone DP reviews

What are the possible side effects of Dalalone DP?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• muscle tightness, weakness, or limp feeling;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• severe depression, unusual thoughts or behavior;

• a seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• fast or slow heart rate, weak pulse;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Dalalone DP can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Dalalone DP.

Common side effects may include:

• fluid retention (swelling in your hands or ankles);

• increased appetite;

• mood changes, trouble sleeping;

• skin rash, bruising or discoloration;

• acne, increased sweating, increased hair growth;

• headache, dizziness;

• nausea, vomiting, upset stomach;

• changes in your menstrual periods; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also:

Dalalone DP side effects (in more detail)

Side effects of Dalalone DP in details

Clinical Studies Experience: Treatment of Macular Edema: Clinical Studies 206207‐008 and 206207‐009 (Initial 6‐month Treatment Period): The clinical safety of Dalalone DP 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 DP and 423 received sham.

The most frequently reported adverse reactions considered to be related to the intravitreal injection procedure rather than the Dalalone DP 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 DP compared to sham at days 7, 30, 60, and 90. At day 180, there were no significant differences between Dalalone DP and sham.

The proportion of patients experiencing increased IOP with Dalalone DP 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 DP 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 DP 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 DP 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 DP, or sham as their 1st injection, completed the initial treatment period at day 180, and then received Dalalone DP as their 2nd injection. A total of 997 patients received the Dalalone DP 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 DP as their 1st injection followed by Dalalone DP as the 2nd injection. More specifically, subcapsular cataracts in the study eye were notably more common in the Dalalone DP/Dalalone DP group (12.9%) compared to either sham/Dalalone DP (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 DP.

Treatment of Uveitis: Clinical Study 206207‐014: The clinical safety of Dalalone DP 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 DP 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 DP and sham patients who experienced IOP at ≥25 mmHg or ≥35 mmHg in the study eye, at any visit. At week 26, no Dalalone DP 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 DP and sham, except at week 8 where significantly higher percentages were observed with Dalalone DP (9.6%) compared to sham (0%), p=0.013. At week 26, only 1 Dalalone DP patient and 2 sham patients showed an increase from baseline IOP ≥10 mmHg.

The proportion of Dalalone DP‐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 DP 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 DP.

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.

What is the most important information I should know about Dalalone DP?

• Dalalone DP drops may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Tell your doctor or dentist that you take Dalalone DP drops before you receive any medical or dental care, emergency care, or surgery.
• Dalalone DP drops may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.
• Dalalone DP drops can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.
• Diabetes patients -- Dalalone DP drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including may be performed while you use Dalalone DP drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Dalalone DP drops in CHILDREN; they may be more sensitive to its effects.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Dalalone DP drops.
• PREGNANCY and BREAST-FEEDING: It is not known if Dalalone DP drops can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dalalone DP drops while you are pregnant. Dalalone DP drops is found in breast milk. Do not breast-feed while taking Dalalone DP drops.

Dalalone DP contraindications

You should not use this medication if you are allergic to Dalalone DP, or if you have a fungal infection anywhere in your body.

Before taking Dalalone DP, 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 DP. Vaccines may not work as well while you are taking a steroid.

Do not stop using Dalalone DP 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 DP. Any medical care provider who treats you should know that you are using a steroid.

References

1. 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).
2. DTP/NCI. "dexamethasone: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Dexamethasone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Dalalone DP 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 Dalalone DP. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology