Acrotech Biopharma, LLC. Website Linking Policy

Acrotech Biopharma, LLC. (“Acrotech”) ordinarily does not prohibit links to this website, provided that any such link does not improperly connote an endorsement by or affiliation with Acrotech, or otherwise adversely impact Acrotech, and pursuant to the terms below.

If you are interested in linking to this website or any other Acrotech owned websites, please notify Acrotech Biopharma by sending an e-mail to webmaster@acrotechbiopharma.com. Include your name, your organization name, contact information (such as a phone number and/or e-mail address) as well as the URL of your site and a list of any URLs from which you intend to link to this site.

By linking to any page on the Acrotech websites, you hereby agree to be bound by the terms and conditions as set forth below:

Links may be text-based using the words: “ZEVALIN^®“, “ZEVALIN” , “Acrotech^®“, “Acrotech”, or “AcrotechBiopharma.com” the “Acrotech Marks”. You may not use the ZEVALIN^®logo, Acrotech™ logo or any Acrotech logo as a link. By linking, you acknowledge and agree that, other than as set forth herein, all rights to the Acrotech Marks, other Acrotech marks, the content appearing on the Acrotech website and the design of the Acrotech website belong to Acrotech Biopharma, LLC. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by Acrotech Biopharma, LLC.

You may not create frames around any of the pages of the Acrotech™ websites or use other techniques that alter in any way the visual presentation or appearance of any of the Acrotech™ websites.

You must not misrepresent your relationship with any Acrotech™ product or Acrotech Biopharma, LLC. (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity) or present false or misleading impressions about any Acrotech™ product or Acrotech Biopharma, LLC. (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity). No links to any Acrotech™ website may be used in a manner that implies or suggests that Acrotech approves or endorses you, your website or your goods and services (in all cases, except as Acrotech may have agreed separately with you in writing).

Acrotech has no responsibility or liability for any content appearing on your website. You agree to indemnify and defend Acrotech against all claims arising out of or based upon your website.

No link(s) may appear on any page on your website or within any context containing content or materials that may be interpreted as libelous, obscene or criminal, or which infringes, otherwise violates, or advocates the infringement or other violation of, any third party rights.

Acrotech may at any time, in its sole discretion, without cause, terminate your right to link to any web pages of any Acrotech™ website. In such event, upon request, you agree to immediately remove all links to any Acrotech™ website and to cease using the Acrotech Marks.

Acrotech Biopharma, LLC, reserves the right to change this linking policy at any time. Changes will be posted on this page.

ZEVALIN Important Safety Information

Indications and Usage

ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one infusion of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin’s lymphoma (NHL).

The ZEVALIN therapeutic regimen is used to treat adult patients with:

Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL)
Previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy

Patient Important Safety Information

What Is The Most Important Safety Information I Should Know About ZEVALIN Treatment?

The following section provides an overview of important safety information you should know about ZEVALIN, including side effects. Not all of the safety information about ZEVALIN treatment is included here. For complete safety information, please see the accompanying full prescribing information for ZEVALIN or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide.

WARNING: ZEVALIN TREATMENT CAN CAUSE SERIOUS SIDE EFFECTS:

- Serious Infusion Reactions: Rituximab, alone or as part of the ZEVALIN treatment, may cause serious infusion reactions. Deaths have occurred within 24 hours of rituximab infusion, an important component of the ZEVALIN treatment. Tell your doctor or infusion nurse or get medical treatment right away if you develop fever or chills, a rash, itching, dizziness, swelling of your hands, feet or face, throat irritation or trouble breathing during or after receiving the ZEVALIN treatment.
- Extended and Severe Decreases in Your Blood Counts (Cytopenias): Your doctor will monitor your blood counts after receiving the ZEVALIN treatment. Decreased blood counts can occur late and continue for more than 12 weeks after receiving ZEVALIN. Tell your doctor if you have a fever, feel too tired to do daily activities, feel weak, develop bruises or pinpoint red or purple spots on your skin, have unusual bleeding or notice blood in your urine or stool.
- Severe Skin or Mucous Membrane Reactions: If you experience any reactions related to your skin or mucous membranes (e.g. mouth, nose), your infusion of rituximab and Y-90 ZEVALIN should be discontinued.

Dosing Warning: The dose of Y-90 ZEVALIN should not exceed 32.0 mCi (1184 MBq).

Additional Safety Information:

Risk of Developing Myelodysplastic Syndrome, Leukemia and Other Malignancies (Cancers): The radiation dose resulting from therapeutic exposure to Y-90 ZEVALIN may result in secondary malignancies.Myelodysplastic syndrome (MDS; a type of pre-cancerous bone marrow abnormality) and/or Acute Myelogenous Leukemia (AML, a type of cancer of the blood) were reported in 5.2% (11/211) of patients treated with Y-90 ZEVALIN for relapsed or refractory non-Hodgkin’s lymphoma (NHL) in clinical studies, and 1.5% (8/535) of all patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to diagnosis of MDS or AML was 1.9 years following the ZEVALIN therapy; however, the total incidence continues to increase.
Among 204 newly diagnosed patients who received Y-90 ZEVALIN, following complete or partial response to initial anticancer therapy, 26 (12.7%) patients in the Zevalin arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm. Seven patients (3.4%) were diagnosed with MDS/AML after receiving ZEVALIN treatment, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to secondary new malignancies occurred in 8 (3.9%) patients treated with ZEVALIN compared to 3 (1.5%) patients in the control arm of the study. Deaths due to MDS or AML occurred in 5 (2.5%) patients treated with ZEVALIN compared to no patients in the control arm.

Your doctor will monitor you for toxic effects to the blood, including development of MDS or AML.

Infusion Site Leakage: ZEVALIN may leak from your vein or infusion site. Your doctor will monitor you during treatment and will stop the infusion and switch to another vein, if this occurs during treatment.
Immunization: Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
Precautions During and After Administration: Your doctor will discuss precautions with you to minimize radiation exposure.
Potential for Birth Defects: ZEVALIN therapy may cause harm to the fetus. Please tell your doctor if you are pregnant or plan to become pregnant. If you are a male and your female partner is pregnant or plans to become pregnant please tell your doctor. You will need to use birth control during treatment and for a minimum of 12 months following ZEVALIN therapy.
Reproductive Organs: Based in its radioactivity, there is a potential risk that Zevalin therapeutic regimen could cause toxic effects on the male and female gonads. .
Lactation: Due to the potential for serious adverse reactions in a breastfeeding child from Zevalin, advice lactating women to avoid breastfeeding during treatment with Zevalin therapeutic regimen and for 6 months after the last dose.
Adverse Reactions (Side Effects): The most common adverse reactions (≥10%) in clinical trials with ZEVALIN were: decreases in blood counts, tiredness, inflammation of the nose and upper throat, nausea (upset stomach), abdominal (stomach) pain, weakness, cough, diarrhea, and fever. The most serious adverse reactions of ZEVALIN are prolonged and severe reduction in the number of blood counts and secondary cancers.When administered following initial anticancer therapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe decrease in blood counts (decrease in platelets [51%], decrease in neutrophils (a type of White Blood Cell) [41%], decrease in total white blood cells [36%], decrease in Lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]). Reductions in blood cells were more severe and more prolonged among 11 (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing anticancer regimen as compared to patients receiving non fludarabine-containing regimens. grade 3/4 infections occurred in 8% of ZEVALIN-treated patients and in 2% of controls and included neutropenic sepsis (fever and infection due to decrease in the number of neutrophils [1%]), bronchitis, catheter sepsis (bacterial infection in the blood related to catheter), diverticulitis (inflammation in the intestines), shingles or blistering skin rash caused from herpes virus reactivation, flu, lower air passage infection, sinusitis (swelling of the sinuses), and upper air passage infection.
grade 3/4 adverse reactions of ZEVALIN in recurring NHL patients include prolonged and severe reduction of blood cells (decrease in platelets [63%], decrease in neutrophils [60%], decrease in red blood cells or hemoglobin [17%], and ecchymosis (small blue or purple patch on the skin or mucous membrane [<1%])). Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis (type of skin infection), colitis (swelling of the large intestine), diarrhea, osteomyelitis (bone infection), and upper-air passage infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema (collection of pus in a cavity in the body), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).

Please see the accompanying full Prescribing Information, including the BOXED WARNINGS, for ZEVALIN. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

ISI-ZEV-0317